Methods and apparatus for treating disorders of the ear nose and throat

ABSTRACT

Methods and apparatus for treating disorders of the ear, nose, throat or paranasal sinuses, including methods and apparatus for dilating ostia, passageways and other anatomical structures, endoscopic methods and apparatus for endoscopic visualization of structures within the ear, nose, throat or paranasal sinuses, navigation devices for use in conjunction with image guidance or navigation system and hand held devices having pistol type grips and other handpieces.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 14/568,498,filed Dec. 12, 2014, published as U.S. Pub. No. 2015/0165176 on Jun. 18,2015, which is a continuation of application Ser. No. 11/193,020, filedJul. 29, 2005, now abandoned, which is a continuation-in-part ofapplication Ser. No. 11/150,847, filed Jun. 10, 2005, now U.S. Pat. No.7,803,150, issued Sep. 28, 2010, which is a continuation-in-part of U.S.patent application Ser. No. 10/829,917 entitled Devices, Systems andMethods for Diagnosing and Treating Sinusitis and Other Disorders of theEars, Nose and/or Throat filed on Apr. 21, 2004, now U.S. Pat. No.7,654,997, issued Feb. 2, 2010; Ser. No. 10/944,270 entitled Apparatusand Methods for Dilating and Modifying Ostia of Paranasal Sinuses andOther Intranasal or Paranasal Structures filed on Sep. 17, 2004,published as U.S. Pub. No. 2006/0004323 on Jan. 5, 2006, now abandoned;Ser. No. 11/116,118 entitled Methods and Devices for PerformingProcedures Within the Ear, Nose, Throat and Paranasal Sinuses filed Apr.26, 2005, now U.S. Pat. No. 7,720,521, issued May 18, 2010 , each suchapplication being expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical apparatus and methodsand more particularly to devices and methods that are useable to treatdisorders of the paranasal sinuses as well as other ear, nose & throatdisorders.

BACKGROUND OF THE INVENTION

Functional endoscopic sinus surgery (FESS) is currently the most commontype of surgery used to treat chronic sinusitis. In a typical FESSprocedure, an endoscope is inserted into the nostril along with one ormore surgical instruments. The surgical instruments are then used to cuttissue and/or bone, cauterize, suction, etc. In most FESS procedures,the natural ostium (e.g., opening) of at least one paranasal sinus issurgically enlarged to improve drainage from the sinus cavity. Theendoscope provides a direct line-of-sight view whereby the surgeon istypically able to visualize some but not all anatomical structureswithin the surgical field. Under visualization through the endoscope,the surgeon may remove diseased or hypertrophic tissue or bone and mayenlarge the ostia of the sinuses to restore normal drainage of thesinuses. FESS procedures can be effective in the treatment of sinusitisand for the removal of tumors, polyps and other aberrant growths fromthe nose.

The surgical instruments used in the prior art FESS procedures haveincluded; applicators, chisels, curettes, elevators, forceps, gouges,hooks, knives, saws, mallets, morselizers, needle holders, osteotomes,ostium seekers, probes, punches, backbiters, rasps, retractors,rongeurs, scissors, snares, specula, suction canulae and trocars. Themajority of such instruments are of substantially rigid design.

In order to adequately view the operative field through the endoscopeand/or to allow insertion and use of rigid instruments, many FESSprocedures of the prior art have included the surgical removal ormodification of normal anatomical structures. For example, in many priorart FESS procedures, a total uncinectomy (e.g., removal of the uncinateprocess) is performed at the beginning of the procedure to allowvisualization and access of the maxilary sinus ostium and/or ethmoidbulla and to permit the subsequent insertion of the regid surgicalinstruments. Indeed, in most traditional FESS procedures, if theuncinate process is allowed to remain, such can interfere withendoscopic visualization of the maxillary sinus ostium and ethmoidbulla, as well as subsequent dissection of deep structures using theavailable rigid instrumentation.

More recently, new devices, systems and methods have been devised toenable the performance of FESS procedures and other ENT surgeries withminimal or no removal or modification of normal anatomical structures.Such new methods include, but are not limited to, uncinate-sparingBaloon Sinuplasty™ procedures and uncinate-sparing ethmoidectomyprocedures using catheters, non-rigid instruments and advanced imagingtechniques (Acciarent, Inc., Menlo Park, Calif.). Examples of these newdevices, systems and methods are described in incorporated U.S. patentapplication Ser. No. 10/829,917 entitled Devices, Systems and Methodsfor Diagnosing and Treating Sinusitis and Other Disorders of the Ears,Nose and/or Throat; issued as U.S. Pat. No. 7,7654,997 on Feb, 2, 2010;Ser. No. 10/944,270 entitled Apparatus and Methods for Dilating andModifying Ostia of Paranasal Sinuses and Other Intranasal or ParanasalStructures; now abandoned; Ser. No. 11/116,118 entitled Methods andDevices for Performing Procedures Within the Ear, Nose, Throat andParanasal Sinuses filed Apr. 26, 2005, issued as U.S. Pat. No. 7,720,521on May 18, 2021 and Ser. No. 11/150,847 entitled Devices, Systems AndMethods Useable For Treating Sinusitus filed on Jun. 10, 2005, issued asU.S. Pat. No. 7,803,150 on Sep. 28, 2010, of which this application is acontinuation-in-part.

There remains a need for further development of new and differentdevices and methodology for surgical treatment of sinusitis and otherear, nose and throat disorders.

SUMMARY OF THE INVENTION

The present invention provides apparatus and disorders for treatingsinusitis and other disorders of the ear, nose, throat and paranasalsinuses. The various devices and methods of the present invention may beused separately or in any possible and desirable combinations with eachother.

In accordance with the invention, there is provided endoscopic guidesystems that generally comprise tubular guides (e.g., rigid, flexibleand/or malleable guide catheters) that incorporate or are attachable toendoscopic apparatus. The endoscopic apparatus is useable to enableendoscopically view areas ahead of or adjacent to the distal end of thetubular guide. In some embodiments, such endoscopic guide systems areuseable to facilitate trans-nasal advancement of a guidewire, catheter,instrument or other device to a position within or near an opening or aparanasal sinus (e.g., any transnasally accessible opening in aparanasal sinus or air cell including but not limited to; natural ostia,surgically altered natural ostia, surgically created openings,antrostomy openings, ostiotomy openings, burr holes, drilled holes,ethmoidectomy openings, natural or man made passageways, etc.). Tofacilitate this, the endoscopic guide system may comprise a) a tubularguide having a proximal end, a distal end and a lumen that extendslongitudinally therethrough, said tubular guide having a distal portionthat is more flexible than the remainder of the guide and said tubularguide being configured such that it may be i) inserted, distal endfirst, through a nostril of the subject's nose and ii) advanced, withoutrequiring substantial modification or removal of any normal anatomicalstructure, to a position where the distal end of the guide is within oradjacent to the ostium of the paranasal sinus; and b) an endoscopicdevice incorporated in or attached to the tubular guide, said endoscopicdevice being useable to view a visual field that includes an area beyondthe distal end of the tubular guide. In some embodiments, a portion(e.g., a distal portion) of the tubular guide may be curved and theendoscopic apparatus may allow to user to essentially see around thecurve. The endoscopic apparatus may comprise a rigid, flexible,deflectable or steerable endoscopes that is incorporated into, insertedinto or through, or attached to the tubular guide. Or, the endoscopicapparatus may comprise a waveguide, periscope or other device thatserves as an extension of a separate endoscope such that the endoscopemay be connected (e.g., attached, inserted, coupled or otherwiseassociated) to the proximal end of the endoscopic apparatus and willreceive an image from the distal end of the endoscopic apparatus.

Further in accordance with the invention, there are provided seekerdevices that are useable to locate or access structures within the ear,nose and throat. In some embodiments, these seeker devices have lumensextending therethrough. In such embodiments having lumens, guidewiresmay be inserted or advanced through the lumen, thereby providingseeker/guidewire systems that are useable for placing guidewires intovarious anatomical structures (e.g., into a paranasal sinus). Inembodiments having lumens, the proximal end of the seeker device may beattachable to a source of fluid for irrigation or substance deliverythrough the lumen and/or to a source of negative pressure to permitsuction through the lumen. Also, in some embodiments that have lumens, aslot opening may extend along all or a portion of the lumen to allow aguidewire or other elongate device to be extracted laterally from all ora portion of the lumen. Additionally or alternatively, in someembodiments, the seeker device may have an expandable member (e.g., aballoon) that is useable to dilate anatomical structures, anchor theseeker and/or for other purposes. Structurally, a seeker device of thepresent invention may comprise an elongate substantially rigid (e.g.,straight, pre-shaped, bent, curved, malleable) shaft, optionally havinga bulbous (e.g., enlarged) distal tip on one or both ends. Variouscurves may be formed or formable in the seeker shaft.

Still further in accordance with the invention, there are provideddilator devices (e.g., balloon dilators) that may be used to dilateanatomical structures within the ear, nose or throat of a human oranimal subject (e.g., opening of paranasal sinuses as defined hereabove,metal passageways, other openings or passages). Such dilator devices maycomprise a) a handpiece, b) an elongate shaft that extends from thehandpiece, such elongate shaft having a distal portion that isinsertable through a nostril of the subject's nose, c) a dilator havinga non-expanded configuration and an expanded configuration and a dilatorexpansion control or trigger apparatus on or associated with thehandpiece, such dilator expansion control or trigger apparatus beinguseable to move the dilator between its non-expanded configuration andits expanded configuration. In some embodiments, the dilator may beadvanceable (or advanceable/retractable) from the elongate shaft. Insuch embodiments having an advanceable or advanceable/retractabledilator, the handpiece may additionally have a dilator advancementcontrol or trigger. In some designs of these devices, the handpiece,dilator expansion control or trigger and/or dilator advancement controlor trigger may be operable by one hand, thereby leaving the operatorsother hand free for handling other instruments or performing othertasks. In embodiments where the dilator comprises a balloon, theexpansion of the dilator may result for the provision of a flow ofinfusion fluid into the balloon. Accordingly, such devices mayincorporate pumps and/or sources of pressurized inflation fluid tofacilitate inflation of the balloon. The balloon may be compliant ornon-compliant. In embodiments having non-compliant balloons, the devicemay additionally comprise apparatus for applying negative pressure tothe balloon thereby evacuating and collapsine the non-compliant balloon.

Further still in accordance with the invention, there are provideddevices for deterring unwanted movement of catheter(s) or otherdevice(s) (e.g., guidewires, endoscopes, dilators, etc.) that have beeninserted into the nose of a human or animal subject. Such support devicemay generally comprise a support member (e.g., an elongate body) that ispositionable adjacent to the subject's nose and an attachment substanceor apparatus (e.g., adhesive, resilient or pliable projections, fingers,members, hook and loop connector material, other apparatus forfrictional engagement, etc.). The attachment substance or apparatus isuseable for releaseably holding the catheter(s) or other device(s) insubstantially fixed position relative to the support member.Additionally, these devices may comprise positioning apparatus (e.g.,legs, brackets, holders, adhesive) for holding the support member inposition adjacent to the subject's nose.

Still further in accordance with the invention, there are providedballoon catheters that are constructed in new ways. Such ballooncatheters have guidewire lumens that extend though some or all of thelength of the catheter. In some embodiments, an optional slot openingmay be formed along some or all of the length of the guidewire lumen toallow a guidewire or other device to be extracted laterally from all ofrpart of that lumen.

Further still in accordance with the invention, there are providedballoon folding tools that are useable to facilitate folding ofcatheter-mounted balloons, such as non-compliant balloons. A balloonfolding tool of this invention may comprise a) a rigid body having acentral bore formed therein, the central bore having a diameter that isless than the fully inflated balloon diameter, b) a plurality of sidechannels located adjacent to and substantially parallel with the centralbore, each of such side channels being connected to the bore through aslot. The balloon is insertable into the central bore while in a lessthan fully inflated state. Thereafter the balloon is inflatable to afully or partially inflated state causing a separate portion of theballoon to pass through the each slot and into each side channel.Thereafter the balloon is deflatable such that each separate portion ofthe balloon that has passed into each side channel will form a separatewing of the deflated balloon. Those wings are, thereafter, foldable to acollapsed shape.

Even further in accordance with the invention, there are providedapparats for compressing balloons to a low profile to facilitatesubsequent insertion or reinsertion of the balloon into the body of ahuman or animal subject. Such a balloon compression apparatus maycomprise a plurality of compression members disposed radially about acentral cavity, such compression members being spaced apart from eachother such that gaps exist between adjacent compression members, suchcompression members being moveable from non-compressing positions tocompressing positions. The balloon is insertable into the central cavityof the compression device while the compression members are in theirnon-compressing positions. The compression members are then moveable totheir compressing positions, thereby compressing portions of the ballooncausing any inflation fluid to be forced out of the balloon and causingportions of the balloon to protrude outwardly into the gaps between thecompression members. This results in the formation of a plurality ofwings an the deflated balloon, such wings being thereafter foldable intoa collapsed shape.

Still further in accordance with the invention, there are providedinflator handpiece devices that are attachable to balloon catheters orother balloon equipped devices (e.g., balloon equipped tubular guides,seekers, guidewires, etc, as described herein and elsewhere) and useableto inflate the balloon. An inflator handpiece of the present inventionmay comprise a) a handpiece body configured to be grasped by a humanhand, such handpiece body being attachable to the proximal end of aballoon catheter or other balloon equipped device, b) an inflator (e.g.,a pump or source of compressed inflation fluid) and an inflation triggeruseable to cause the inflator to inflate the balloon. These handpiecesmay facilitate precise handling and positioning of balloon catheters andother balloon equipped devices. In some embodiments, the handpiece maycomprise and elongate body having a grip member that extends at an anglefrom the elongate body (e.g., generally similar to a pistol grip type ofarrangement). In some embodiments, the handpiece and inflation triggermay be configured to be useable by a single hand, thereby freeing theoperators other hand for handling of other instruments or performingother tasks. In embodiments where the catheter or other balloon equippeddevice has a lumen useable for passage of a guidewire or other device orsubstance, the inflator handpiece device may incorporate a port orpassage to permit a guidewire or other device to be advanced throughthat lumen and/or to permit fluids to be infused or suction appliedthrough that lumen. Various valves, grippers, etc. may be associatedwith such passageway or port to provide hemostasis, prevent fluidleakage, deter unwanted movement of guidewires or devices, etc.

Further yet in accordance with the present invention, there are provideddevices for breaking nasal turbinates or other bony anatomicalstructures in a human or animal subject. Such a breaking device maycomprise a) first and second members positionable at spaced apartpositions on one side of the turbinate or bony structure and a thirdmember positionable on the other side of the turbinate or bonystructure, between the first and second members. The third member and/orsaid first and second members are then moveable to exert pressure on thenasal turbinate or bony structure to cause the bone of the nasalturbinate or bony structure to break.

Still further in accordance with the invention, there are providednavigation adapters that are attachable to cannulae, catheters orelongate devices to facilitate their use in conjunction with navigationsystems (e.g., optical, electromagnetic, etc.) of the type used inperforming image guided surgery. Such navigation adapter may comprise a)an elongate adapter body that is attachable to the substantially rigidcannula, catheter or elongate device and b) apparatus useable by theimage guidance system to determine the position of the substantiallyrigid cannula, catheter or elongate device within the body of a human itanimal subject. The apparatus useable by the image guidance system maycomprise various sensors, emitters, reflectors, transponders, reflectivepassive elements, light emitting diodes, transmitters or receivers ofenergy (e.g. optical energy, radiofrequency energy, etc.) orcombinations thereof that are useable to enable a navigation system totrack the position of catheter, cannula or other device within the body.Examples of commercially available navigation systems that may beuseable in conjunction with these navigation adapters include but arenot limited to (insert list from navigation application).

Still further in accordance with the invention, there are providedmethods for using the above summarized devices.

Further yet in accordance with the present invention, there are providedmethods where one or more anatomical structures (e.g. uncinate process,wall of ethmoid air cell, turbinate) and/or pathological structures(e.g., polyps, etc) are removed or modified in combination with aprocedure where a dilator is inserted transnasally and used to dilate anopening of a paranasal sinus (as defined hereabove) or other anatomicalstructure within the ear, nose, throat or paranasal sinus of a human oranimal subject. Such removal or modification of normal or pathologicalanatomical structures may facilitate visualization and/or access tovarious anatomical locations during and after the procedure.

Still further in accordance with the invention, there is provided anasal introducer that comprises an introducer body (e.g., a plug) thatinsets into the nostril of a human or animal subject. One or morelumen(s) (e.g., passageway(s) or bore(s)) extend through the introducerbody to allow one or more catheters or other devices (e.g., endoscopes,dilators, seekers, tubular guides, etc.) to be advanced through theintroducer and into the nasal cavity or beyond. Various valves,grippers, etc. may be associated with such lumen(s) to providehemostasis, prevent fluid leakage and/or deter unwanted movement ofcatheters or other devices that have been inserted through the lumen(s).

Further aspect, elements and advantages of the present invention will beunderstood by those of skill in the art upon reading of the detaileddescription set forth herebelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a human subject undergoing a procedurefor treating sinusitus in accordance with the present invention.

FIG. 2A shows a perspective view of an embodiment of a support devicehaving finger members in the nature of bristles.

FIG. 2B shows a perspective view of an embodiment of a support devicehaving finger members in the nature of pliable or resilient projections.

FIG. 2C shows a perspective view of an embodiment of a support devicecomprising an adhesive surface.

FIGS. 2D through 2G show perspective views of various embodiments of asupport device being used to support a working device.

FIGS. 3-3A show an embodiment of a nasal introducer that is insertablein to nares of a human or animal subject and useable to facilitatesubsequent insertion and handling of catheters and other devices.

FIG. 4A shows a perspective view of an embodiment of a guidewirecomprising an enlarged distal end.

FIG. 4B shows a longitudinal sectional view of an embodiment of aguidewire comprising an anchoring balloon.

FIG. 5A shows a cross sectional view of a first embodiment of a seekerdevice having a lumen.

FIG. 5B shows a perspective view of a second embodiment of a seekerdevice having a lumen.

FIG. 5C shows a cross section of the seeker in FIG. 5B through the plane5C-5C.

FIG. 5D shows a cross sectional view of a third embodiment of a seekerdevice comprising a lumen.

FIG. 5E shows a longitudinal section of an embodiment of a seeker devicecomprising a deflectable or bendable distal tip.

FIG. 5F shows a cross sectional view through plane 5F-5F in FIG. 5E.

FIG. 6A is a perspective, partially section view of a tubular guidehaving a balloon.

FIG. 6B is a cross sectional view through line 6B-6B of FIG. 6A.

FIG. 6C shows a perspective view of a tubular guide having a separatelumen useable for insertion of an endoscope.

FIG. 6D shows a perspective view of a tubular guide having clip(s)useable for attachment of an endoscope or other apparatus.

FIG. 6E shows an embodiment of a combination endoscope and tubularguide.

FIG. 6F shows another embodiment of a combination endoscope and tubularguide.

FIG. 6G shows another embodiment of a combination endoscope and tubularguide.

FIGS. 6H and 6I show apparatus useable to hold a tubular guide and anendoscope in substantially fixed side-by-side positions.

FIG. 6J shows a perspective view of a removable clip device useable forattaching a second device (e.g., an endoscope) to a tubular guide orother elongate device.

FIGS. 6K and 6L show steps in a method wherein the removable clip deviceof FIG. 6J is used to attach an endoscope to a tubular guide.

FIGS. 6M through 6O show steps of a method of introducing one or morediagnostic or therapeutic devices through a tubular guide having anassociated endoscope.

FIG. 6P shows a method for introducing a dilator through a tubular guidethat has an associated endoscope.

FIG. 6Q shows a perspective view of a combination endoscope/tubularguide that is bendable or deflectable.

FIG. 6R shows the distal end of the device of FIG. 6Q in a bent ordeflected state.

FIGS. 7A-7C show a method for advancing a guidewire or other devicethrough the working lumen of an endoscope into an anatomical openingviewed by the endoscope.

FIG. 8A shows a perspective view of a tubular guide equipped foroptional suctioning.

FIG. 8B shows a perspective view of a guide having a handpiece that isconfigured to receive a detachable navigational modality to facilitateuse of the device in an image guided surgical or interventionalprocedure.

FIG. 9 shows a perspective view of a tubular guide having a taperedconnector on its proximal end to facilitate attachment of a suction tubeto the tubular guide.

FIG. 10A is an exploded view showing the components of a tubular guidedevice formed of a straight proximal segment and a curved distalsegment.

FIG. 10B is an assembled view of the device shown in FIG. 10A.

FIG. 10C shows a distal portion of a tubular guide comprising apolymeric inner tube and an outer tube having apertures, wherein thepolymeric material of the inner tube is caused to flow or protrudethrough the apertures thereby holding the inner tube in substantiallyfixed position within the outer tube.

FIG. 11 shows a side-deflecting distal tip that may be formed on orattached to a tubular cannula or catheter.

FIG. 12 shows the distal portion of a guide catheter having a pluralityof lumens through which guidewires or other devices may be introduced ondifferent trajectories.

FIG. 12A is a cross sectional view through line 12A-12A of FIG. 12.

FIG. 13A shows a distal portion of a tubular guide having a curvedendoscopic apparatus attached thereto.

FIG. 13B is a longitudinal sectional view of an endoscopic apparatus inthe nature of a periscope.

FIG. 13C is a longitudinal sectional view of an endoscopic apparatus inthe nature of a curved wave guide.

FIGS. 13D-E show steps in a method wherein the device of FIG. 13A isused in combination with a straight endoscope to accomplish position ofthe distal tip of the tubular guide at an obscured anatomical locationwithin the body of a human or animal subject.

FIG. 14A is a perspective view of a straight tubular guide of thepresent invention having an endoscopic device attached thereto orintegrated therewith and an optional balloon.

FIG. 14B is a perspective view of a curved tubular guide of the presentinvention having an endoscopic device attached thereto or integratedtherewith and an optional balloon.

FIG. 14B′ is a view of the distal portion of the tubular guide device ofFIG. 14B showing details of the curve formed therein.

FIG. 14C is a perspective view of another curved tubular guide of thepresent invention having an endoscopic device attached thereto orintegrated therewith and an optional balloon.

FIG. 14C′ is a view of the distal portion of the tubular guide device ofFIG. 14C showing details of the curve formed therein.

FIG. 14D is a perspective view of another curved tubular guide of thepresent invention having an endoscopic device attached thereto orintegrated therewith and an optional balloon.

FIG. 14D′ is a view of the distal portion of the tubular guide device ofFIG. 14D showing details of the curve formed therein.

FIG. 14E is a perspective view of another curved tubular guide of thepresent invention having an endoscopic device attached thereto orintegrated therewith and an optional balloon.

FIG. 14E is a view of the distal portion of the tubular guide device ofFIG. 14E showing details of the curve formed therein.

FIG. 15 is a perspective view of a balloon catheter constructed of firstand second tubes such that a short lumen (e.g., a rapid exchangeguidewire lumen) extends through the balloon.

FIG. 15A is a cross sectional view through line 15A-15A of FIG. 15.

FIG. 16 is a perspective view of a balloon catheter constructed offirst, second and third tubes such that a short lumen (e.g., a rapidexchange guidewire lumen) extends through the balloon.

FIG. 16A is a cross sectional view through line 16A-16A of FIG. 16.

FIG. 16B is a cross sectional view through line 16B-16B of FIG. 16.

FIG. 16C is a cross sectional view through line 16C-16C of FIG. 16.

FIG. 17 is a broken, partially sectional view of a balloon catheterhaving a stylet permanenetly positioned therein and a guidewire tipprotruding from its distal end.

FIG. 17A is a cross sectional view through line 17A-17A of FIG. 17.

FIG. 17B is a partial perspective view of the stylet of the ballooncatheter shown in FIG. 17.

FIG. 18 is a broken, partially sectional view of a balloon catheterhaving a side slit.

FIG. 18A is a cross sectional view through line 18A-18A of FIG. 18.

FIG. 18B is a cross sectional view through line 18B-18B of FIG. 18.

FIG. 19 shows a partial perspective view of the distal region of anotherballoon catheter that has capacitance measuring means for real timedetermination of balloon diameter.

FIG. 19A shows a side view of the distal region of the balloon catheterof FIG. 21.

FIG. 19B is a cross sectional view through line 19B-19B of FIG. 19A.

FIG. 19C is a cross sectional view through line 19C-19C of FIG. 19A.

FIG. 20 shows a partial perspective view of the distal region of anotherballoon catheter that has capacitance measuring means for real timedetermination of balloon diameter.

FIG. 20A shows a side view of the distal region of the balloon catheterof FIG. 20.

FIG. 20B is a cross sectional view through line 20B-20B of FIG. 20A.

FIG. 20C is a cross sectional view through line 20C-20C of FIG. 20A.

FIG. 21 shows a partial perspective view of a distal portion of ballooncatheter having a malleable distal shaft.

FIG. 22 shows a partial perspective view of a distal portion of ballooncatheter having a flexible distal shaft.

FIG. 23 shows a partial perspective view of a balloon folding tool ofthe present invention.

FIG. 23A shows a balloon catheter being inserted into the balloonfolding tool of FIG. 23.

FIG. 23B shows a cross sectional view of the balloon folding tool ofFIG. 23 with a fully deflated/collapsed balloon positioned therein.

FIG. 23C shows a cross sectional view of the balloon folding tool ofFIG. 23 with a balloon partially inflated therein such that positions ofthe balloon protrude into side channels.

FIG. 23D shows a deflated/collapsed balloon after removal from theballoon folding tool of FIG. 23.

FIG. 24 is a front perspective view of a balloon compressing apparatusof the present invention.

FIG. 24A is an exploded view of the balloon compressing apparatus ofFIG. 24.

FIG. 25 shows a longitudinal sectional view of an embodiment of acatheter for simultaneous aspiration and irrigation of an anatomicalregion.

FIG. 26 is a perspective view of a navigation adapter device that isattachable to a variety of other devices to facilitate use of thoseother devices in image guided surgical or interventional procedures.

FIG. 26A is a perspective view of the navigation adaptor device of FIG.26 attached to the proximal end of a guide tube of the present inventionand having an optical navigation assembly mounted on the navigationadapter device.

FIG. 26B is a perspective view of the navigation adaptor device of FIG.26 attached to the proximal end of a guide tube of the present inventionand having an electromagnetic navigation assembly mounted on thenavigation adapter device.

FIG. 27A is a top view of a dilation device useable to dilate the ostiaof paranasal sinuses and other anatomical passages within the ear, noseand throat.

FIG. 27B is a side view of the device of FIG. 27A.

FIGS. 27C-27D show steps in a method for using the dilation device ofFIGS. 27A-27B.

FIG. 27E is a side view of another dilation device useable to dilateopenings of paranasal sinuses and other anatomical passages within theear, nose and throat.

FIG. 27F is a side view of another dilation device which uses compressedinflation fluid to inflate a dilator balloon to dilate openings ofparanasal sinuses and other anatomical passages within the ear, nose andthroat.

FIG. 27G is a schematic diagram of the valving arrangement of the deviceshown in FIG. 27F.

FIG. 27H is a partial sectional view through a portion of the device ofFIG. 27A-B.

FIG. 28A is a perspective view of a hand grip inflator device attachedto a balloon catheter.

FIG. 28B is a perspective view of a balloon dilation device having ahand grip inflator.

FIG. 29 shows a perspective view of a hand-held squeezing device useableto break or deform anatomical structures such a nasal turbinates.

FIG. 29A shows a distal portion of the device of FIG. 29 in an openposition.

FIG. 29B shows a distal portion of the device of FIG. 29 in a closedposition.

FIGS. 29C-D show steps in a method for temporarily or permanentlybreaking or deforming a nasal turbinate using the squeezing device ofFIG. 29.

FIG. 29E shows a broken perspective view of a twistable device that isuseable to break or deform anatomical structures such a nasalturbinates,

FIGS. 29F-G show steps in a method for temporarily or permanentlybreaking or deforming a nasal turbinate using the twisting device ofFIG. 29E.

FIG. 30 is a flow diagram of a method useable for treating sinusdisorders by removal or modification of an anatomical or pathologicalstructure in combination with dilation of an opening of a paranasalsinus.

FIG. 31 is a flow diagram of a method useable for treating sinusdisorders by dilation of an opening of a paranasal sinus in combinationwith suction and/or irrigation of a sinus cavity.

FIG. 32 is a flow diagram of a method useable for treating conditionswhere unwanted scar or adhesion tissue has formed by forming a puncturetract in the scar or adhesion tissue, inserting a dilator into thepuncture tract and dilating the puncture tract.

FIG. 33 a flow diagram of a method useable for treating sinus disordersby dilation of a natural opening of a paranasal sinus in combinationwith the creation of a new opening in the paranasal sinus.

DETAILED DESCRIPTION

The following detailed description, the accompanying drawings and theabove-set-forth Brief Description of the Drawings are intended todescribe some, but not necessarily all, examples or embodiments of theinvention. The contents of this detailed description do not limit thescope of the invention in any way.

A number of the drawings in this patent application may show anatomicalstructures of the ear, nose and throat. In general, these anatomicalstructures are labeled with the following reference letters:

-   -   Nasal Cavity NC    -   Nasopharynx NP    -   Nasal Turbinate NT    -   Frontal Sinus FS    -   Frontal Sinus Ostium FSO    -   Ethmoid Sinus ES    -   Ethmoid Air Cells EAC    -   Sphenoid Sinus SS    -   Sphenoid Sinus Ostium SSO    -   Maxillary Sinus MS    -   Maxillary sinus ostium MSO    -   Mucocyst MC    -   Middle turbinate MT    -   Inferior turbinate IT    -   Uncinate UN    -   Suprabullar ostium/recess SO    -   Retro-bullar ostium/recess RO

The devices disclosed herein may be used alone or in variouscombinations to perform various procedures including, but not limitedto, various transnasal procedures within paranasal sinuses and/or withinopenings of paranasal sinuses. As used herein, unless specifiedotherwise, the term “opening(s) of paranasal sinus(es)” shall includeany transnasally accessible opening in a paranasal sinus or air cellincluding but not limited to; natural ostia, natural canals, surgicallyaltered natural ostia, surgically created openings, antrostomy openings,ostiotomy openings, burr holes, drilled holes, puncture tracts,ethmoidectomy openings, fenestrations and other natural or man madepassageways.

FIG. 1 shows a human subject undergoing a procedure for treatingsinusitis in accordance with one particular example of the presentinvention. The human subject is subjected to one or more diagnostic,therapeutic or access devices introduced through a support device 100.One example of a therapeutic device is a balloon catheter used to dilateopenings of paranasal sinuses or other endonasal anatomical structures.One example of an access device is a guidewire used to access dilatenatural ostia of paranasal sinuses or a natural or artificial passagewayor tract leading to paranasal sinuses. In the embodiment shown in FIG.1, support device 100 comprises a support member that is stabilized bythree or more legs that rest on the operating table. The one or morediagnostic, therapeutic or access devices may be tracked or navigatedthrough the anatomy using one or more tracking or navigation modalities.In the embodiment shown in FIG. 1, a C-arm fluoroscope 102 providesfluoroscopic visualization of anatomical regions during the procedure.An instrument console 104 comprising one or more functional modules mayalso be provided. Instrument console 104 can be controlled by consolecontrol means e.g. a foot pedal controller, a remote controller etc.Instrument console 104 may be fitted with wheels to enable an operatorto change the position of the instrument console in an operating area.Instrument console 104 may comprise functional modules including, butnot limited to:

1. Suction pump for delivering a controlled amount of vacuum to asuction device,

2. Irrigation pump to deliver saline or other suitable irrigationmedium,

3. Power module to supply power to drills or other electrical devices,

4. Storage modules for storing instruments, medications etc.,

5. Energy delivery module to provide radiofrequency, laser, ultrasoundor other therapeutic energy to a surgical device,

6. Fluoroscope, MRI, CT, Video, Endoscope 106 or Camera or other imagingmodules to connect or interact with devices used during variousdiagnostic or therapeutic procedures,

7. Display module e.g. a LCD, CRT or Holographic screen to display datafrom various modules such as an endoscope, fluoroscope or other data orimaging module,

8. Remote control module to enable an operator to control one or moreparameters of one or more functional modules, and

9. Programmable Microprocessor that can store one or more operationsettings for one or more functional modules etc.

In the embodiment shown in FIG. 1, instrument console 104 is connectedto endoscope 106. Endoscope 106 may be introduced in the anatomy throughone or more introducing devices 108 such as guide catheters. A physicianmay use a hand held introducer 110 comprising a surgical navigationmodality to introduce one or more diagnostic, therapeutic or accessdevices into the anatomy. Examples of surgical navigation modalitiesthat may be located on introducer 110 include, but are not limited tonavigation modalities comprising reflective passive elements, lightemitting diodes, transmitters or receivers of energy (e.g. opticalenergy, radiofrequency energy, etc.), a combination of tow or more ofthe abovementioned navigation modalities, etc.

One or more devices disclosed herein may be supported by one or moresupport devices while performing diagnostic, therapeutic or accessprocedures on a patient. For example, FIG. 2A shows a perspective viewof one embodiment of a support device 200 comprising an elongate,generally cylindrical body 202 having a plurality of projections 204(e.g., strands, wires, bristles, pliable or resilient members, etc.)extending therefrom. Projections 204 are located sufficiently close toeach other and are made of a suitable material to frictionally grip adevice that has been inserted between adjacent projections 204. Forexample, projections 204 may be made of polymers, rubber materialsincluding, but not limited to neoprene, silicone rubber, ABS, Nylon,PVC, Pebax, etc. Projections 204 can be used to reversibly support oneor more devices while performing diagnostic, therapeutic or accessprocedures on a patient. In some embodiments, one or more attachmentsubstances or apparatus may be used to attach the body 202 to a regionof the patient's body such as face, head, etc; a table; a flexible,rigid or repositionable arm mounted on a support; etc. In the embodimentshown in FIG. 2A, body 202 is attached to four arms 206 that enablesupport device 200 to be placed on a suitable surface.

FIG. 2B shows a perspective view of another embodiment of a supportdevice. In this example, the support device 210 comprises a and elongatebody 212 having having an adhesive material disposed on one or moreregions of its outer surface to reversibly adhere the support device 216to a surface, such as the patient's body, a table or a flexible arm,etc. The body 212 of this support device 210 further comprises two ormore fingers 214 constructed and spaced in relation to each other tofrictionally grip and substantially hold device(s) (e.g., catheter,cannula, endoscope, guidewire, etc.) that has been inserted betweenadjacent fingers 214. The fingers 214 may be formed of any suitablematerial, typically a pliable or resilient material such as certainpolymer foams, elastomers, rubber materials including, but not limitedto neoprene, silicone rubber, ABS, Nylon, PVC, Pebax, etc. Fingers 214can be used to frictionally hold one or more device(s) (e.g., catheter,cannula, endoscope, guidewire, etc.) in substantially fixed positionwhile performing diagnostic, therapeutic or access procedures on apatient. Body 212 is connected to one or more attachment mechanisms toattach body 212 to a region such as the patient's body, a table or aflexible arm, etc.

FIG. 2C shows a perspective view of another embodiment of a supportdevice 216 comprising an elongate body having one or more regions of itsouter surface coated with an adhesive material to which one or moredevice(s) (e.g., catheter, cannula, endoscope, guidewire, etc.) mayreleasably adhere. The body of this support device 216 may be made ofany suitable biocompatible materials including, but not limited tosilicone, nylon, DELRIN®, polycarbonate, stainless steel, ABS, etc.Typical examples of adhesives that may be disposed on the outer surfaceof the body to include, but are not limited to medical grade rubberpressure sensitive adhesives, acrylic adhesives such as 3M Emtechadhesive P1500™, 3M Emtech adhesive P1510™, etc. The adhesive coatedregions may also be used to reversibly adhere the body of this supportdevice 216 to another surface such as the patient's body, a table or aflexible arm, etc.

FIGS. 2D through 2G show perspective views of various embodiments ofsupport devices being used to support working devices. In FIG. 2D,support device 210 is reversibly attached to a the patient's face. FIG.2D also shows a guide catheter 226 introduced through the nose andsupported between adjacent fingers 214 of the support device 210 withthe elongate body of the support device being disposed transverseley(e.g., from side to side) inferior to the subject's nose (e.g., belowthe nares).

In the example of FIG. 2E, a support device 230 comprises a body 232 andtwo or more thin strands, wires, or bristles 234 that are connected tobody 232. Bristles 234 are designed to frictionally grip a devicelocated between adjacent bristles 234. Body 232 is connected to one ormore attachment mechanisms such as arms 236 that enable support device230 to be placed on a patient's face. In the embodiment shown in FIG.2E, a guide catheter 238 is supported by support device 230.

In FIG. 2F, a support device 240 comprises a body 242 and two or morethin strands, wires, or bristles 244 that are connected to body 242. Oneregion of body 242 is in contact with a facial region of a patient.Bristles 244 are designed to frictionally grip a device located betweenadjacent bristles 244. Body 242 is connected to one or more attachmentmechanisms such as arms 246 that enable support device 240 to besupported on a patient's face. In the embodiment shown in FIG. 2F, aguide catheter 248 is supported by support device 240.

In FIG. 2G, a support device 250 comprises a body 252 and two or morethin strands, wires, or bristles 254 that are connected to body 252.Bristles 254 are designed to frictionally grip a device located betweenadjacent bristles 254. Body 252 is connected to one or more attachmentmechanisms such as arms 256 that enable support device 250 to be placedon a mount table. In the embodiment shown in FIG. 2G, a guide catheter258 is supported by support device 250.

Similar support devices may also be designed using hook and loopfasteners such as Velcro™.

One or more devices disclosed herein may be introduced through one ormore nasal introducers. Such nasal introducers may also be used forkeeping catheters or devices separate from each other and/or foranchoring for deterring unwanted movement or slippage of one or morecatheter or other devices that have been inserted into the nose. Suchnasal introducers may also be used for plugging the nostrils to preventleakage of fluids through the nostril. For example, FIGS. 3-3A show anembodiment of a nasal introducer that is insertable in to nares of ahuman or animal subject and useable to facilitate subsequent insertionand handling of catheters and other devices. FIG. 3 shows a perspectiveview of an embodiment of the nasal introducer 300 comprising a bodyhaving a proximal region, a distal region and one or more lumens orbores extending therethrough to permit insertion of the desireddevice(s). The outer diameter of proximal region is larger than theouter diameter of the distal region. The outer diameter of nasalintroducer 300 gradually reduces or tapers in the distal direction, asshown in FIG. 3. This nasal introducer 300 is placed in a nostril andone or more diagnostic, therapeutic or access devices may be introducedthrough nasal introducer 300. Examples of such diagnostic, therapeuticor access devices include, but are not limited to guide catheters,guidewires, endoscopes, etc. In the example shown in FIGS. 3 and 3A, thenasal introducer 300 has two lumens, a first device introducing lumen302 and a second device introducing lumen 304. The proximal end of firstdevice introducing lumen 302 emerges out of the proximal end of nasalintroducer 300 through a first opening 306. The distal end of firstdevice introducing lumen 302 emerges out of the distal end of nasalintroducer 300 through a second opening 307. Similarly, the proximal endof second device introducing lumen 304 emerges out of the proximal endof nasal introducer 300 through a third opening 308. The distal end ofsecond device introducing lumen 304 emerges out of the distal end ofnasal introducer 300 through a fourth opening 309. In one embodiment,first opening 306 and third opening 308 are provided with a lockingmechanism such as a rotating hemostasis valve. The locking mechanism canbe used to anchor one or more devices being introduced through nasalintroducer 300 to the nose. Nasal introducer 300 may be made of suitablebiocompatible materials including, but not limited to rubber, polymers,metals, etc.

FIG. 4A shows a side view of an embodiment of a guidewire comprising anenlarged distal end. Guidewire 400 comprises an elongate body 402.Elongate body 402 may be made of a variety of biocompatible materialsincluding, but not limited to stainless steel, Nickel-titanium alloy(e.g., Nitinol), etc. Elongate body 402 may be coated with a variety ofguidewire coatings including, but not limited to lubricious coatingssuch as PTFE coatings, etc. The distal end of elongate body 402comprises an enlarged region 404. In one embodiment, enlarged region 404is substantially spherical in shape. The length of elongate body 402 mayrange from 65 to 75 cm. The distal region of guidewire 400 may comprisea curved, bent or angled region. In one embodiment, the distal region ofguidewire 400 comprises a J-tip.

In some method embodiments of the invention disclosed herein, aguidewire may be inserted into a paranasal sinus or into/near theopening of a paranasal sinus and, thereafter, one or more diagnostic ortherapeutic devices may be introduced over the guidewire. In someinstances, forces generated during introduction of devices over theguidewire may tend to cause the position of the guidewire to change. Theforces may also cause the guidewire to get dislodged from a desiredposition in a paranasal sinus or opening of a paranasal sinus. Toprevent such unwanted movement of the guidewire, one or more anchoringor occlusion apparatus may be present on the guidewire. For example,FIG. 4B shows a longitudinal sectional view of a guidewire 410 having anelongate body 412, a lumen 414 and a balloon 416 or other inflatablemember that may be used to anchor the distal end of the guidewire 410 orfor other purposes (e.g., dilation). Elongate body 412 may be made of avariety of biocompatible materials including, but not limited tostainless steel, Nickel-titanium alloy (e.g., Nitinol), etc. In oneembodiment, elongate body 412 is made of a suitable hypotube. Elongatebody 412 may be coated with a variety of guidewire coatings including,but not limited to lubricious coatings such as PTFE coatings, etc. Theouter diameter of elongate body 412 may range from 0.014 inches to 0.040inches. In a preferred embodiment, the outer diameter of elongate body412 is 0.035 inches. Elongate body 412 comprises a lumen 414. The distalend of lumen 414 is in fluid communication with an anchoring balloon416. Anchoring balloon 416 may be made of a compliant, semi-compliant ornon-compliant material. Anchoring balloon 416 may be present on thedistal end of elongate body 412 or on the distal region of elongate body412. The proximal region of elongate body 412 may comprise a microvalvelocated in lumen 414. The microvalve allows a user to inflate or deflateanchoring balloon 416 and also provide a fluid seal to lumen 414 whenguidewire 410 is used to perform a diagnostic or therapeutic procedure.The distal region of guidewire 400 may comprise a curved, bent or angledregion. In one embodiment, the distal region of guidewire 400 comprisesa J-tip. In one embodiment of a method of using guidewire 400, distalend of guidewire 400 is introduced into an anatomical region such as aparanasal sinus with anchoring balloon 416 deflated. Thereafter,anchoring balloon 416 is inflated. Guidewire 400 is then pulled in theproximal direction to anchor anchoring balloon 416 in the ostium of theparanasal sinus. Thereafter, guidewire 400 is used to perform adiagnostic or therapeutic procedure. It will be appreciated that, as analternative to a balloon 416, other anchoring apparatus such asdeployable projections or expandable polymer or metal mesh structuresmay be incorporated into or on the guidewire 410.

Various diagnostic, therapeutic or access devices disclosed herein maybe introduced in the anatomy through a seeker. FIG. 5A shows a seekerdevice 500 that comprises an elongate body 502 having a lumen 506extending therethrough. The elongate body 502 can be made of suitablebiocompatible material(s) including, but not limited to metals e.g.stainless steel, titanium, nickel-titanium alloy (e.g., Nitinol), etc.;polymers e.g. Pebax, PEEK, Nylon, polyethylene, etc. Some or all of theelongate body 502 may be bent, angled, curved or malleable. The distalend of elongate body 502 may comprise a tip structure 504. Such tipmember 504 may be constructed to be substantially atraumatic so as toprevent or reduce damage to adjacent anatomy while using seeker 500. Inthe embodiment shown in FIG. 5A, tip structure 504 comprises anenlarged, substantially spherical or bulbous region. Lumen 506 extendsfrom the proximal end of elongate body 502 and to the distal end of thedevice. The lumen 506 can be used for introducing one or more elongatedevices, suctioning, introducing one or more fluids, etc. The proximalend of elongate body 502 may comprise a suitable hub such as a luerlock. Seeker 500 may be introduced through an opening in the human bodyto determine the location of a cavity, sinus or other anatomicalregions. Thereafter, one or more elongate devices such a guidewires maybe inserted through lumen 506 and into the cavity, sinus or otheranatomical regions. In one method embodiment, seeker 500 is insertedthrough the nose into the nasal cavity. Thereafter, seeker 500 isadvanced such that optional tip structure 504 is located near a targetanatomy e.g. an opening of a paranasal sinus. Seeker 500 is then movedby the user such that atraumatic tip 504 engages with the targetanatomy. This provided the user information about the location andorientation of the target anatomy such as an ostium or passagewayleading to a paranasal sinus. Seeker 500 is then used to introduce aguidewire through lumen 506 into the paranasal sinus. Thereafter, seeker500 is removed leaving the guidewire in place. The guidewire is thenused to introduce one or more diagnostic or therapeutic devices into theparanasal sinus. In another method embodiment, an endoscope may beincorporated within or introduced through lumen 506 and used tovisualize anatomical structures and/or to guide the navigation of seeker500. Optionally, a dilator (e.g., a balloon) may be mounted on theseeker 500 at or near the distal end of the device and may be used todilate structures into which the seeker device 500 has been inserted. Ininstances where a balloon or other inflatable dilator is used, a secondlumen may extend through the shaft 502 terminating distally in anopening within the balloon to permit inflation/deflation of the balloon.

FIGS. 5B-C show a second embodiment of a seeker device 510 comprising anelongate body 512 having a lumen 518 extending therethrough from end toend. Elongate body 512 can be made of suitable biocompatible materialsincluding, but not limited to metals e.g. stainless steel, titanium,Nickel-titanium alloy (e.g., Nitinol), etc.; polymers e.g. Pebax, PEEK,Nylon, polyethylene, etc. The distal region of elongate body 512 maycomprise a bent, angled or curved region. In some embodiments, some(e.g., a distal region) or all of the elongate body 512 may besubstantially curved or malleable. The distal end of elongate body 512may, in some cases, comprise an atraumatic tip 514 to prevent or reducedamage to adjacent anatomy while using seeker 510. In the embodimentshown in FIG. 5B, atraumatic tip 514 comprises an enlarged,substantially spherical region. The proximal region of elongate body 512may comprise a handle 516 to enable a user to advance and/or twistseeker 510. In the particular example of FIG. 5B, the lumen 518 extendsfrom the proximal end of elongate body 512 to through distal end of theatraumatic tip 514. Also, in this particular example, the elongate body512 further comprises a longitudinal slit 520 that extends into lumen518. The proximal end of elongate body 512 may comprise a suitable hubsuch as a luer lock. In one method of use, this seeker 510 may beinserted through the nose into the nasal cavity. Thereafter, seeker 510is advanced such that atraumatic tip 514 becomes positioned near atarget anatomy e.g. an ostium of a paranasal sinus. Seeker 510 is thenmoved by the user such that its atraumatic tip 514 touches adjacentanatomical structures. This provides the user with information about thelocation and orientation of the target anatomy and/or surroundinganatomical structures. In some applications, after the atraumatic tip514 of the seeker 510 has been inserted into or through an ostium of aparanasal sinus, a guidewire may be advanced through lumen 518 into theparanasal sinus. Thereafter, the seeker 510 may be removed leaving theguidewire in place. To facilitate removal of the seeker 510 whileleaving the guidewire in place, the proximal portion of the guidewiremay be extracted laterally through slit 520. After the seeker 510 hasbeen removed, the guidewire may be used to introduce one or more workingdevices (e.g., diagnostic or therapeutic devices) into the paranasalsinus. In some applications, an endoscope is introduced through lumen518 to guide the navigation of seeker 510. FIG. 5D shows Another seeker530 comprising an elongate body 532 having a lumen 534 extendingtherethrough. The body 532 may be made of suitable biocompatiblematerials including, but not limited to metals e.g. stainless steel,titanium, Nickel-titanium alloy (e.g., Nitinol), etc.; polymers e.g.Pebax, PEEK, Nylon, polyethylene, etc. The distal region of elongatebody 532 may comprise a bent, angled or curved region. In oneembodiment, elongate body 532 is substantially malleable. Lumen 534 isan end-to-end lumen extending from the proximal end of elongate body 532through an opening in the distal end of elongate body 532. A guidewire536, which may optionally have an atraumatic tip 538, is loaded in lumen534 as shown. The distal region of guidewire 536 may be curved, bent orangled such that it forms an internal angle, for example an angle ofabout 30 degrees, about 60 degrees, about 90 degrees, about 110 degrees,etc. The proximal end of elongate body 532 may comprise a suitable hubsuch as a rotating hemostasis valve to reversibly secure guidewire 536to seeker 530. In one method embodiment, seeker 530 along with guidewire536 is inserted through the nose into the nasal cavity. Thereafter,seeker 530 is advanced such that atraumatic tip 538 is located near atarget anatomy e.g. an ostium of a paranasal sinus. Seeker 530 is thenmoved by the user such that atraumatic tip 538 engages with the targetanatomy. This provided the user information about the location andorientation of the target anatomy. Seeker 530 is then used to advanceguidewire 536 through lumen 534 into the paranasal sinus. Thereafter,seeker 530 is removed leaving guidewire 536 in place. This step isperformed by sliding seeker 530 in the proximal direction over guidewire536. Guidewire 536 is then used to introduce one or more diagnostic ortherapeutic devices into the paranasal sinus.

Any of the seeker devices disclosed herein may comprise a deflectable orbendable distal tip. For example, FIG. 5E shows a seeker device 540having a deflectable or bendable distal tip. Seeker 540 comprises anelongate body 542 having a first lumen 544 and a second lumen 546extending therethrough. The elongate body 542 may be made from suitablebiocompatible material(s) including, but not limited to Pebax, PEEK,Nylon, polyethylene, etc. The distal end of elongate body 542 mayoptionally comprise an atraumatic tip. In one embodiment, the distal endof elongate body 542 comprises an enlarged, spherical region. In theembodiment shown in FIG. 5E, the inner diameter of the first lumen 544is larger than the inner diameter of the second lumen 546. The proximalend of elongate body 542 may be connected to a suitable hub 548, such asa female luer lock. Hub 548 may comprise one or more wings 550 to enablea user to twist or torque seeker 540. Seeker 540 further comprises adeflecting or bending mechanism. In this embodiment, the deflecting orbending mechanism comprises a deflecting handle 552 attached to a pivot554. One end of deflecting handle 552 is connected to a pull wire 556.The distal end of pull wire 556 is attached to the distal region ofelongate body 542 by an attachment means 558. In one embodiment,attachment means 558 is glue. To cause deflecting or bending of thedistal tip of elongate body 542, a user pulls deflecting handle 552.Deflecting handle 552 in turn pulls pull wire 556. This causesdeflecting or bending of the distal tip of elongate body 542. FIG. 5Fshows a cross sectional view through plane 5F-5F in FIG. 5E. FIG. 5Fshows elongate body 542 comprising first lumen 544 and second lumen 546.Pull wire 556 passes through second lumen 546. Similar deflectingmechanisms may also be used for constructing one or more guide cathetersdisclosed herein. Such guide catheters may be used for introducing oneor more diagnostic, therapeutic or access devices into the anatomy.

Any of the seeker devices disclosed herein may be used to open orpuncture scar tissue or adhesions of paranasal sinus ostia orpassageways leading to paranasal sinuses. Such scar tissue or adhesionsmay be caused for example due to infection, prior surgery, etc.

FIG. 6A shows a tubular guide or guide catheter 600 having an elongateguide shaft 602, a lumen 603 extending therethrough and an expandabledilator such as a balloon 606. Guide shaft 602 may be made of suitablebiocompatible materials including, but not limited to metals e.g.stainless steel, titanium, nickel-titanium alloy (e.g., Nickel-titaniumalloy (e.g., Nitinol)), etc.; polymers e.g. Pebax, PEEK, Nylon,polyethylene, etc. The distal region of guide shaft 602 may comprise anangled, curved or bent region. In one embodiment, the distal tip ofguide catheter 600 comprises a soft, atraumatic tip to reduce or preventdamage to surrounding anatomy. The distal region of guide shaft 602 maycomprise a navigational marker 604 such as a radiopaque marker band or asensor/emitter usable with an electromagnetic or other type ofnavigation or image guidance system. Balloon 606 may be made of suitablebiocompatible materials including, but not limited to PET, Nylon, PVC,polyurethane, silicone, etc. Balloon 606 can be inflated by a hollowballoon inflation tube 608. Balloon inflation tube 608 is attached toguide shaft 602 and is substantially collinear to guide shaft 602. Theproximal end of balloon inflation tube 608 is in fluid connection to aballoon inflation port 610. The proximal end of guide shaft 602 maycomprise a suitable hub such as a female luer lock 612. Guide catheter600 can be used for introducing one or more devices or fluids throughlumen 603. Lumen 603 can also be used for suctioning fluids. Balloon 606may be used for dilating anatomical regions including, but not limitedto anatomical passageways, ostia of paranasal sinuses, etc. FIG. 6Bshows a cross sectional view through the plane 6B-6B of FIG. 6A. FIG. 6Bshows balloon inflation tube 608 is attached to guide shaft 602.

FIG. 6C shows a guide catheter 620 that has an elongate body 622comprising a lumen and a side channel, such as a side tube 626. Elongatebody 622 may be made of suitable biocompatible materials including, butnot limited to metals e.g. stainless steel, etc. or polymers e.g. Pebax,PEEK, etc. The distal end of elongate body 622 may comprise a curved,angled or bent region. The distal end of elongate body 622 may comprisea malleable region or may be actively deflectable by a user. Theproximal end of elongate body 622 comprises a hub 624. In oneembodiment, hub 624 is a female luer lock. The side lumen 626 may bealigned substantially parallel to the lumen of elongate body 622 and mayextend distally to be flush with the distal end of the elongate body 622or, in some cases, may terminate proximal to the distal end of theelongate body. In the particular example shown in the drawings, sidelumen 626 extends from a proximal region of guide catheter 620 to alocation that is substantially flush with the distal end of the elongatebody 622. Side lumen 626 may be permanently or detachably attached toelongate body 622. A suitable endoscope 628 or other imaging device orimaging probe can be introduced through elongate side lumen 626 suchthat the distal end of endoscope 628 emerges out of the distal end ofelongate side lumen 626. Examples of suitable endoscopes 628 that can beused with guide catheter 620 include Karl Storz FlexibleRhino-Laryngoscope (11101RP), made by Karl Storz Endoscopy—America,Culver City, Calif. The proximal end of endoscope 628 is connected to avideo camera 630 to enable a user to view the anatomy around the distalregion of guide catheter 620. This combination of guide catheter 620 andendoscope 628 is introduced in a target anatomy. Thereafter, one or morediagnostic, therapeutic or access devices are introduced through thelumen of elongate body 622 under endoscopic guidance. The curved, angledor bent region in the distal end of elongate body 622 is especiallyuseful to navigate endoscope 628 around a tight bend in the anatomy.

FIG. 6D shows a guide catheter 650 having an elongate body 652, a lumenthat extends through the elongate body and one or more attachmentapparatus such as side clip(s) 656. Elongate body 652 may be made ofsuitable biocompatible materials including, but not limited to metalse.g. stainless steel, etc. or polymers e.g. Pebax, PEEK, etc. The distalend of elongate body 652 may comprise a curved, angled or bent region.The proximal end of elongate body 652 may comprise a hub 654. In oneembodiment, hub 654 is a female luer lock. Side clips 656 may bepermanently or removably attached to the outer surface of elongate body652 as shown in FIG. 6C. The one or more side clips 656 may form achannel through which an endoscope may be introduced or may otherwisehold an endoscope in a position beside the elongate body 652 such thatthe endoscope may view a field ahead of or adjacent to the distal end ofthe device 650. Thus, one or more diagnostic, therapeutic or accessdevices may be introduced through the lumen of elongate body 652 underendoscopic guidance using an endoscope (or other imaging device orprobe) that has been inserted or os other wise positioned within orsupported by side clips 656. In one embodiment, side clips 656 may becylindrical. In another embodiment, side clips 656 may be ring shaped.

FIG. 6E shows an endoscope 660 or other imaging device or imaging probeis combined with a guide catheter 662. Guide catheter 662 has a lumen.Guide catheter 662 may comprise a bent, angled or curved distal tip 664.In this particular example a magnet 666 causes the endoscope 660 to beattached by magnetic force to the guide catheter 662, as shown in FIG.6D. This combination of endoscope 660 and guide catheter 662 is thenintroduced in the anatomy. Thereafter, one or more diagnostic,therapeutic or access devices may be introduced through the lumen ofguide catheter 662 under endoscopic guidance or other image guidanceusing an endoscope 660 or other imaging device or imaging probe attachedby magnetic force to the guide catheter 662.

FIG. 6F shows an endoscope 670-guide catheter 672 combination device orsystem. In this example, the guide catheter 672 has a lumen. Guidecatheter 672 may comprise a bent, angled or curved distal tip 674. Inthis embodiment, endoscope 670 is combined with guide catheter 672 by anattachment apparatus that comprises a collar, such as a rubber collar676. Rubber collar 676 comprises two parallel lumens. Endoscope 670 fitsin the first lumen of rubber collar 676. Rubber collar 676 may be madeof suitable biocompatible rubber materials including, but not limited tosilicone, Pebax, PVC, etc. Similarly, guide catheter 672 fits in thesecond lumen of rubber collar 676. Thus, endoscope 670 is combined withguide catheter 672 to enable simultaneous introduction of endoscope 670and guide catheter 672 into a target anatomy. Thereafter, one or morediagnostic, therapeutic or access devices are introduced through thelumen of guide catheter 672 under endoscopic guidance.

FIG. 6G shows an endoscope 680—guide catheter 682 combination device orsystem. Guide catheter 682 has a lumen and may comprise a bent, angledor curved distal tip 684. In this embodiment, endoscope 680 is combinedwith guide catheter 682 by a removable band 686 that ties endoscope 680with guide catheter 682. In one embodiment, removable band 686 comprisesa hook and loop type of attaching mechanism such as Velcro. Removableband 686 may be made of suitable biocompatible materials including, butnot limited to silicone, Pebax, nylon, stainless steel, Nickel-titaniumalloy (e.g., Nitinol)™), etc. Thus, endoscope 680 is combined with guidecatheter 682 to enable simultaneous introduction of endoscope 680 andguide catheter 682 into a target anatomy. Thereafter, one or morediagnostic, therapeutic or access devices are introduced through thelumen of guide catheter 682 under endoscopic guidance.

FIGS. 6H and 6I show another endoscope-guide catheter combination deviceor system 698. As seen in FIG. 6H, the guide catheter comprises anelongate shaft 690. In some cases, a distal region of elongate shaft 690may further comprise a curved, bent or angled region 692. The guidecatheter further comprises a hub 694 located on the proximal end ofelongate shaft 690. In one embodiment, hub 694 is a female luer lock.The guide catheter is attached to an endoscope 696 such as a fiber-opticendoscope by an adjustable connector 698 comprising a hollow body 699.Hollow body 699 comprises two channels: a first channel comprising afirst proximal orifice 6000 and a first distal orifice 6002 and a secondchannel comprising a second proximal orifice 6004 and a second distalorifice 6006. The first channel allows the guide catheter to passthrough adjustable connector 698. The second channel allows endoscope696 to pass through adjustable connector 698. Adjustable connectorcomprises a first gripping mechanism 6008 and a second grippingmechanism 6010. First gripping mechanism 6008 enables adjustableconnector 698 to grip the guide catheter. Similarly, second grippingmechanism 6010 enables adjustable connector 698 to grip endoscope 696.In the embodiment shown in FIG. 6H, first gripping mechanism 6008comprises an elongate lever 6012 pivoted on a pivot 6014 located onadjustable connector 698. One end of elongate lever 6012 is attached bya spring mechanism 6016 to adjustable connector 698. Spring mechanism6016 causes the distal end of elongate lever 6012 to press on the guidecatheter. This in turn causes the guide catheter to press on an edge offirst proximal orifice 6000 and first distal orifice 6002. This in turncauses adjustable connector 698 to grip the guide catheter. Similarly,second gripping mechanism 6010 comprises an elongate lever 6018 pivotedon a pivot 6020 and a spring mechanism 6022 to cause adjustableconnector 698 to grip endoscope 696. To adjust the relative positions ofthe guide catheter and/or the endoscope 696, a user presses the proximalregions of elongate lever 6012 and/or elongate lever 6018 as shown inFIG. 6I. Pressing the proximal region of elongate lever 6012 causes thedistal region of elongate lever 6012 to move away from the guidecatheter. This in turn releases the guide catheter from adjustableconnector 698. Similarly, pressing the proximal region of elongate lever6018 releases endoscope 696 from adjustable connector 698. Thus,adjustable connector 698 can be used to maintain the relative positionof the guide catheter and endoscope 696 during introduction or removalof the guide catheter in the anatomy and/or while performing adiagnostic, therapeutic or access procedure. If needed, the relativeposition of the guide catheter and endoscope 696 can be adjusted beforeduring or after a procedure. Various regions of adjustable connector maybe made of suitable biocompatible materials including, but not limitedto metals e.g. stainless steel, Nickel-titanium alloy (e.g., Nitinol),titanium, etc.; suitable polymers, etc. Similarly, other embodiments ofadjustable connectors can be used to maintain the relative position ofthe guide catheter and endoscope 696 during introduction or removal ofthe guide catheter in the anatomy and/or while performing a diagnostic,therapeutic or access procedure.

FIG. 6J shows a perspective view of an embodiment of a removableattachment apparatus comprising a clipping device 6030 useable tointroduce or support an endoscope, image apparatus or various otherdevices along side a guide catheter 6020. In the example shown, guidecatheter 6020 comprises an elongate hypotube 6022 enclosing an elongatetubular member 6024. Elongate tubular member 6024 encloses a lumen toallow for insertion of one or more devices through guide catheter 6020.The distal end of tubular member 6024 may be angled, bent or curved. Thedistal end of tubular member 6024 may comprise an atraumatic tip 6026.The proximal end of tubular member 6024 comprises a hub. In oneembodiment, the hub is a female luer lock. A removable clipping device6030 can clip on to guide catheter 6020. Clipping device 6030 can bemade of suitable biocompatible materials such as metals, rubbers,polymers, etc. Clipping device 6030 comprises a first clip 6032 and asecond clip 6034. First clip 6032 is adapted to attach to the outersurface of guide catheter 6020. Second clip 6034 is adapted to attach tothe outer surface of an endoscope. Such a combination of an endoscopeand a device such as a guide catheter can be introduced by a physicianusing a single hand.

FIGS. 6K and 6L show the steps of a method of accessing an anatomicalregion using the removable clipping device shown in FIG. 6J. In FIG. 6K,clipping device 6030 is attached to guide catheter 6020. Thereafter,guide catheter 6020 is introduced in an anatomical region such as thenasal cavity. An endoscope 6036 is introduced in the anatomy along withguide catheter 6020. Endoscope 6036 helps to visualize the anatomy tofacilitate the introduction and/or the navigation of guide catheter 6020in the anatomy. If desired, endoscope 6036 may be attached to guidecatheter 6020 using clipping device 6030 as shown in FIG. 6L. Thisenables the relative position of endoscope 6036 and guide catheter 6020to be relatively fixed during a procedure. Endoscope 6036 and guidecatheter 6020 can thus be co-introduced in an anatomical region. In oneembodiment, clipping device 6030 is made of a flexible material such asa suitable rubber to allow for angular displacement of the axis ofendoscope 6036 relative to the axis of guide catheter 6020. In anotherembodiment, the contact surface between clipping device 6030 and one orboth of endoscope 6036 and guide catheter 6020 is smooth. This allowsendoscope 6036 to slide relative to guide catheter 6020. In anotherembodiment, endoscope 6036 and/or guide catheter 6020 can be rotatedaround their axes even when attached to clipping device 6030. In anotherembodiment, clipping device 6030 allows minimal motion of endoscope 6036relative to guide catheter 6020.

FIGS. 6M through 6O shows various steps of a method of introducing oneor more diagnostic or therapeutic devices along or beside another devicesuch as an endoscope or other imaging device or imaging probe. In theexample of FIG. 6M, the introducing device 6040 comprises an endoscope6042 and an attachment or receiving apparatus comprising a side lumen6044. Introducing device 6040 is introduced in a desired region of theanatomy. This introduction may be performed using endoscope 6042, usinga separate endoscope or using fluoroscopy or other imaging/guidancetechniques. Thereafter, a guidewire 6046 is introduced through sidelumen 6044. Guidewire 6046 is navigated through the anatomy underendoscopic visualization by endoscope 6042. Thereafter, guidewire 6046is placed in a desired target region. In one method embodiment,guidewire 6046 is placed across an ostium of a paranasal sinus.Thereafter, in FIG. 6N, a working device such as a balloon catheter 6048comprising a dilating balloon 6050 is introduced over guidewire 6046into the target anatomy. Thereafter, in FIG. 6O, balloon 6050 isinflated to dilate a region of the target anatomy. In one methodembodiment, balloon 6050 is inflated to dilate an ostium of a paranasalsinus. Thereafter, balloon 6050 is deflated and balloon catheter 6048and introducing device 6040 are removed form the anatomy. Similarly,other diagnostic or therapeutic devices may be introduced through sidelumen 6044 to perform one or more diagnostic or therapeutic procedures.

FIG. 6P shows an embodiment of a method of introducing a dilator throughthe introducing device of FIG. 6M. In this embodiment, dilator 6052comprises a flexible shaft and a rounded distal end to dilate ordisplace tissue.

FIG. 6Q shows a deflectable introducing device 6054 that generallycomprises an endoscope and an introducing lumen. Introducing device 6054comprises a proximal handle 6056. Proximal handle 6056 encloses anelongate tubular element 6058. In one embodiment, the proximal region oftubular element 6058 is substantially rigid. In another embodiment, thedistal region of tubular element 6058 comprises a bent region. Inanother embodiment, the distal region of tubular element 6058 ismalleable or plastically deformable. In FIG. 6Q, the distal region oftubular element 6058 is removed to show structures enclosed by thedistal region of tubular element 6058. Tubular element 6058 encloses anendoscope 6060 and an introducing lumen 6062. Endoscope 6060 is used tovisualize the anatomy or one or more diagnostic or therapeutic deviceswhile performing a diagnostic or therapeutic procedure. The proximal endof introducing lumen 6062 may comprise a suitable hub 6064. In oneembodiment, hub 6064 is a female luer hub. Introducing lumen 6062 can beused to introduce one or more diagnostic, therapeutic or access devicesinto the anatomy. In one embodiment, introducing device 6054 comprises asteering or deflecting mechanism to allow a user to controllably bend ordeflect the distal region of tubular element 6058. In the embodimentshown in FIG. 6Q, introducing device 6054 comprises a sliding button6066 that is attached to a pull wire. The pull wire in turn is attachedto one or more distal rings 6068 located on the distal region of tubularelement 6058. A user can move sliding button 6066 to cause a distalregion of tubular element 6058 to controllably bend or deflect. Inanother embodiment of a steering or deflecting mechanism, the distalregion of endoscope 6060 is attached to a distal region of tubularelement 6058. The distal region of endoscope 6060 may be attached to adistal region of tubular element 6058 by one or more distal rings 6068.In this embodiment, pulling endoscope 6060 causes a distal region oftubular element 6058 to controllably bend or deflect. FIG. 6R shows aperspective view of the distal region of the introducing device of FIG.6Q in a bent or deflected state. A distal region of tubular element 6058has been removed to show structures enclosed by the distal region oftubular element 6058. Introducing device 6054 may be used to introduceone or more diagnostic, therapeutic or access devices into the anatomy.In one embodiment, introducing device 6054 is used to introduce aballoon catheter. In another embodiment, introducing device 6054 is usedto introduce a guidewire into the anatomy. The guidewire is thereafterused to introduce one or more diagnostic, therapeutic or access devicesinto the anatomy.

FIGS. 7A through 7C show various steps of a method of accessing ananatomical opening using an introducing device 700 that generallycomprises an endoscope 702 and an introducing lumen 704. The introducingdevice 700 may be inserted into the body through an orifice or openingsuch as a nostril. Thereafter, introducing device 700 is positioned,possibly under endoscopic visualization or other image guidance, suchthat the distal end of introducing device 700 is positioned near atarget of interest such as an opening of a paranasal sinus. Thereafter,in FIG. 6S, a diagnostic, therapeutic or access device is insertedthrough introducing lumen 704 into the target of interest. In theexample shown in FIG. 7B, the target of interest is an opening of aparanasal sinus and a guidewire 706 is being inserted throughintroducing lumen 704 into a retro-bullar ostium or recess. Guidewire706 may then be used to introduce one or more diagnostic, therapeutic oraccess into the retro-bullar ostium or recess, as shown. FIG. 7C shows aperspective view of a region of the human face showing the manner inwhich the introducing device 700 may be transnasally inserted in themethod shown in FIGS. 7A and 7B. After the introducing device 700 hasbeen inserted and positioned, various guidewires or other diagnostic,therapeutic or access devices may be inserted through introducing lumen704.

Any of the guide catheters or other luminal devices disclosed herein maycomprise an arrangement for suctioning an anatomical region through thedistal end of the guide catheter or device unless to do so would renderthe device unuseable for its intended purpose. For example, FIG. 8Ashows a guide catheter 800 comprising an elongate tube 802 that may bemade of suitable biocompatible materials including, but not limited tometals such as stainless steel, titanium, Nickel-titanium alloy (e.g.,Nitinol), etc.; plastics such as Pebax, PEEK, Nylon, polyethylene, etc.The distal region of elongate tube 802 may comprise a curved, bent orangled region. In some embodiments, the distal end of elongate tube 802may comprise an atraumatic tip 804. Although various modes ofconstruction may be used, in the example shown, an elongate hypotube 806is disposed on the outer surface of elongate tube 802 and the proximalend of guide catheter 800 comprises a branched or Y-connector 808. Theproximal region of Y-connector 808 comprises a straight arm 810 and aside arm 812. The proximal end of straight arm 810 comprises a suitablehub 814. In one embodiment, hub 814 is a female luer hub. In anotherembodiment, hub 814 comprises a rotating hemostasis valve such as aTouhy-Borst adapter. The proximal end of side arm 812 comprises asuitable hub 816. In one embodiment, hub 816 comprises a rotatinghemostasis valve such as a Touhy-Borst adapter to adjust the amount ofsuction. Hub 816 is connected to a suction tube 818 that providessuction to guide catheter 800. Thus, guide catheter 800 can be used toprovide suction as well as introduce one or more diagnostic, therapeuticor access devices into the anatomy.

Various devices being introduced in the anatomy may comprise adetachable navigation apparatus (e.g., a navigation module or localizer)useable in conjunction with a navigation or image guidance system totrack and/or navigate the devices through the anatomy. For example, FIG.8B shows a perspective view of a guide catheter 820 having a navigationadapter 830 that is designed to receive detachable navigation apparatussuch as a navigation module or localizer containing sensor(s),emitter(s), transmitter(s), reflector(s), etc. that are useable inconjunction with a navigation system. The navigation apparatus may beselected from the various navigation apparatus disclosed herein or inone of the patent applications incorporated herein by reference. In theembodiment shown in FIG. 8B, guide catheter 820 comprises an elongatebody 822 having a lumen. Elongate body 822 may be made of suitablebiocompatible materials including, but not limited to metals e.g.stainless steel, titanium, Nickel-titanium alloy (e.g., Nitinol), etc.;polymers e.g. Pebax, PEEK, Nylon, polyethylene, etc. The distal end ofelongate body 822 may comprise a bent, curved or angled region. Theproximal region of elongate body 822 may comprise a hypotube 824 locatedon the external surface of elongate body 822. The distal end of elongatebody 822 may comprise an atraumatic tip 826. The proximal end of guidecatheter 820 comprises a first attachment mechanism 828. In oneembodiment, first attachment mechanism 828 is a female luer lock. Firstattachment mechanism 828 is used to attach guide catheter 820 to anavigational adaptor 830. Navigational adaptor 830 comprises a secondattachment mechanism 832 that attached to first attachment mechanism 828on the proximal end of guide catheter 820. In one embodiment, secondattachment mechanism 832 is a male luer lock. Navigational adaptor 830further comprises a proximal hub 834 that is in fluid communication withsecond attachment mechanism 832. Navigational adaptor 830 furthercomprises a handle 836 to enable a user to hold and navigate guidecatheter 820. The outer surface of handle 836 may be roughened toincrease the grip of a user on handle 836. In one embodiment, outersurface of handle 836 is roughened by knurling. Handle 836 comprises abay to attach a suitable navigational localizer 838 to navigationaladaptor 830. Examples of navigational localizer 838 are encoded passivemanipulator, active manipulator, ultrasound localizer, electromagneticlocalizer, active optical localizer, passive optical localizer, etc.Navigation adaptor 830 may further comprise an identification module840. Identification module 840 enables navigational localizer 838 toidentify the type of navigational adaptor 830 that is being connected tonavigational localizer 838. This enables the registration of thelocation and orientation of the distal tip of navigational adaptor 830by navigational localizer 838. In the embodiment shown in FIG. 8B,identification module 840 comprises a pair of magnets. The uniquemagnetic field generated by the pair of magnets is measured bynavigational localizer 838. This enables navigational localizer 838 toidentify the type of navigational adaptor 830 being attached tonavigational localizer 838. Other examples of identification module 840include, but are not limited to electrical modules e.g. a ROM thatprovides electrical information to navigational localizer 838;mechanical modules e.g. connector-pin arrangements that providemechanical information to navigational localizer 838; other magneticmodules that provides magnetic information to navigational localizer838; etc. In a particular embodiment, the distal end of elongate body822 comprises a malleable or shapeable region. In this embodiment, theposition and orientation of the distal tip of guide catheter 820 isre-calibrated to navigational localizer 838 after performing a step ofbending or shaping the distal end of elongate body 822.

In an alternate embodiment of navigational adaptor 830 of FIG. 8B,handle 836 may comprise a non-detachable navigational localizer 838.

The devices disclosed herein, especially the guide catheters, maycomprise a proximal region adapted to fit to a suction tube. Forexample, FIG. 9 shows a perspective view of a tubular guide having atapered connector on its proximal end to facilitate attachment of asuction tube to the tubular guide. FIG. 9 shows a tubular guide 900comprising an elongate shaft 902. The proximal end of elongate shaft 902may comprise a suitable hub 904 to attach one or more devices to theproximal end of guide catheter 900. In one embodiment, hub 904 is afemale luer lock. Tubular guide 900 further comprises a tapered region906 on the proximal region of elongate shaft 902. Tapered region 906comprises a wider proximal region and a narrower distal region to allowa suction tube to be fitted on the proximal end of tubular guide 900.One or more grooves or ridges of the external surface of tapered region906 may be provided to increase the grip of the suction tube on taperedregion 906. Tapered region 906 may also be used to attach a tube on theproximal end of tubular guide 900 to deliver a suitable flushing fluid.The distal region of tubular guide 900 may comprise a bent, curved orangled distal region 908.

Bent, curved or angled regions of one or more devices disclosed hereinmay be made by bending a portion of the device and, in some instances,the devices will me formed of malleable material or may incorporate amalleable region to permit the user to bend, curve, angle or otherwiseconfigure the device as desired. Some of the devices disclosed hereinmay be made by joining two elements, one of which comprises a bent,curved or angled region. For example, FIG. 10A is an exploded viewshowing the components of a tubular guide device of FIG. 9 formed of astraight proximal segment 902 and a curved distal segment 908. In thisexample, the bent, curved or angled distal segment 908 is attached tothe proximal segment 902 as shown in the assembled view of FIG. 10B. Thedistal end of proximal region 902 may be joined to the proximal end ofdistal region 908 at any desired angle. This may be done, for example,by cutting the distal end of proximal segment 902 at and angle and/orcutting the proximal end of distal segment 908 at an angle and thenjoining the segments in an end-to-end butt joint fashion. Optionally, asleeve or covering may surround the joint between the proximal end ofthe distal segment 902 and the distal end of the proximal segment 908.Embodiments where the distal segment 908 is joined to the proximalsegment 902 at an angle may be used to make one or more of the devicesdisclosed herein that comprise a bent, curved or angled region.

In an alternate method of manufacture, bent, curved or angled regions ofone or more devices disclosed herein are made by joining two moldedparts. The two molded parts are made such that each molded partcomprises a bent, curved or angled region. The two molded parts are thenjoined to each other to produce a tubular element enclosing a lumen.

FIG. 10C shows a tubular guide or guide catheter 1000 that comprises a afirst tube 1004 and a second tube 1002 that is formed of polymeric orother material that melts or softens so as to be flowable throughopenings 1006 formed in the first tube 1004. The second tube 1002protrudes out of and beyond the distal end of the first tube 1004.Second tube 1002 may be made of suitable biocompatible materialsincluding, but not limited to Pebax, PEEK, Nylon, polyethylene, etc. Thefirst tube 1004 may also be formed of any suitable material such ashypotube made of a biocompatible metals including, but not limited tostainless steel, Nickel-titanium alloy (e.g., Nitinol), etc. Duringmanufacture, the second tube 1002 is positioned such that a proximalportion of the second tube 1002 extends into of through the lumen of thefirst tube 1004 and the second tube 1002 is caused to melt or soften(e.g., by heating) in the area of the openings 1006. The melted orsoftened material of second tube 1002 thereafter enters the one or moreopenings (e.g., holes or notches) 1006 of first tube 1004 and is allowedto resolidify, thereby forming a bond or lock between the first tube1004 and the second tube 1002. Such a method of manufacture may be usedfor manufacturing one or more devices comprising hypotubes disclosedherein or in the patent applications incorporated herein by reference.

FIG. 11 shows a perspective view of an embodiment of a guide cathetercomprising a curved, bent or angled distal flap. Guide catheter 1100comprises an elongate body 1102 comprising a lumen. Elongate body 1102may be made from suitable biocompatible materials including, but notlimited to metals such as stainless steel or Nickel-titanium alloy(e.g., Nitinol), or polymers such as Nylon, Pebax, PEEK, polyethylene,etc. The lumen of elongate body 1102 may be used to introduce one ormore elongate devices through guide catheter 1100. The distal region ofelongate body 1102 comprises a curved, bent or angled distal flap 1104.Flap 1104 is oriented at an angle to the axis of guide catheter 1100 asshown in FIG. 11. In one embodiment, flap 1104 is created by removingmaterial from the distal end of elongate body 1102 and bending thedistal end of elongate body 1102. In another embodiment, flap 1104 iscreated by attaching an element comprising flap 1104 to the distalregion of elongate body 1102. Such guide catheters may be used forintroducing one or more elongate devices such as a guidewire 1106 at adesired angle to the guide catheter.

Similar flap regions may also be attached to the distal end ofendoscopes comprising one or more endoscope lumens. This enables a userto introduce one or more devices through the one or more endoscopelumens at an angle to the axis of the distal region of the endoscope.

FIG. 12 shows a perspective view of a guide catheter comprising anelongate body 1202, lumens 1206, 1210 terminating in openings 1208, 1212and an optional atraumatic distal tip 1204. Atraumatic distal tip 1204prevents or reduces damage to the anatomy while introducing guidecatheter 1200 into the anatomy. Elongate body 6172 may be made fromsuitable biocompatible materials including, but not limited to Nylon,Pebax, PEEK, polyethylene, etc. Guide catheter 1200 further comprises alumen 1206 that extends from the proximal region of guide catheter 1200.The distal end of lumen 1206 emerges out of the distal region of guidecatheter 1200 through a lumen opening 1208. The distal end of lumen 1206comprises a bent, curved or angled region such that an elongate deviceintroduced through lumen 1206 emerges out of lumen opening 1208 at anangle to the axis of guide catheter 1200. Guide catheter 1200 maycomprise one or more lumens. In the example shown in FIG. 12, guidecatheter 1200 further comprises a second lumen 1210 that extends fromthe proximal region of guide catheter 1200. The distal end of secondlumen 1210 emerges out of the distal region of guide catheter 1200through a second lumen opening 1212. FIG. 12A shows a cross sectionthrough the guide catheter shown in FIG. 12 through the plane 12A-12A.Guide catheter 1200 comprises an elongate body 1202 comprising lumen1206 and second lumen 1210. Such guide catheters may be used forintroducing one or more elongate devices such as guidewires at a desiredangle to the guide catheter. Such guide catheters may also comprise anendoscope lumen. In one embodiment, the endoscope lumen has a sideopening to enable a user to introduce one or more elongate devices suchas guidewires under endoscopic guidance.

FIG. 13A shows a tubular guide or guide catheter 1300 comprises anelongate tubular body 1302 that may be substantially rigid and anendoscopic apparatus 1306 attached to the body 1302 and useable tofacilitate endoscopic viewing of a field ahead or or adjacent to thedistal end of the tubular guide body 1302. Elongate body 1302 may bemade of suitable biocompatible materials including, but not limited tometals such as stainless steel, titanium, Nickel-titanium alloy (e.g.,Nitinol), etc.; plastics such as Nylon, Pebax, PEEK, polyethylene, etc.The distal region of elongate body 1302 comprises a curved, bent orangled region to enable the user to introduce one or more devices intothe target region around the anatomical obstruction. The curved, bent orangled region of elongate body 1302 may be bent by an angle ranging from25 degrees to 130 degrees. The distal end of elongate guide 1302 maycomprise an atraumatic tip 1304 to reduce or eliminate trauma tosurrounding tissues while using device guide 1300. In this example, theendoscopic apparatus 1306 comprises a periscope or waveguide that isattached to the side of the tubular body 1302. The proximal end of thisperiscope 1306 comprises a socket 1308. Socket 1308 enables the distalend of an endoscope to attach to periscope 1306. Distal end of periscope1306 comprises a curved, bent or angled region to enable the user tovisualize the target region around the anatomical obstruction. Thecurved, bent or angled region of periscope 1306 may be bent by an angleranging from 25 degrees to 130 degrees. In one embodiment of a method ofusing device guide 1300, the target region around the anatomicalobstruction is visualized by an endoscope attached to periscope 1306.Thereafter, one or more diagnostic, therapeutic or introducing devicesare introduced into the target region through elongate body 1302. FIG.13B shows a longitudinal sectional view of the device guide shown inFIG. 13A. FIG. 13B shows device guide 1300 comprising an elongate body1302 with an atraumatic tip 1304. The proximal end of periscope 1306comprises a socket 1308. Socket 1308 comprises a gasket 1312 tosubstantially seal the interface between an endoscope and socket 1308.The distal end of periscope 1306 comprises lens 1310. Light enteringlens 1310 is reflected by a mirror 1314 and is directed towards socket1308. Thereafter, the light enters the endoscope to provide the user animage of the target anatomy to be visualized. In one alternateembodiment, the mirror may be polarized to improve image quality andreduce glare.

FIG. 13C shows a longitudinal sectional view of a second embodiment of adevice guide comprising a periscope to enable a user to endoscopicallyvisualize a target region around an anatomical obstruction. Device guide1320 comprises an elongate body 1322 comprising a lumen. Elongate body1322 may be made of suitable biocompatible materials including, but notlimited to metals such as stainless steel, titanium, Nickel-titaniumalloy (e.g., Nitinol), etc.; plastics such as Nylon, Pebax, PEEK,polyethylene, etc. The distal region of elongate body 1322 comprises acurved, bent or angled region to enable the user to introduce one ormore devices into the target region around the anatomical obstruction.The curved, bent or angled region of elongate body 1322 may be bent byan angle ranging from 25 degrees to 130 degrees. The distal end ofelongate guide 1322 may comprise an atraumatic tip 1324 to reduce oreliminate trauma to surrounding tissues while using device guide 1320. Aperiscope 1326 is attached lengthwise to elongate body 1320. Distal endof periscope 1326 comprises a curved, bent or angled region to enablethe user to visualize the target region around the anatomicalobstruction. The curved, bent or angled region of periscope 1326 may bebent by an angle ranging from 25 degrees to 130 degrees. The proximalend of periscope 1326 comprises a socket 1328. Socket 1328 enables thedistal end of an endoscope to attach to periscope 1326. Socket 1328comprises a gasket 1330 to substantially seal the interface between anendoscope and socket 1328. The distal end of periscope 1326 comprises alens 1332. Periscope 1326 further comprises fiber optic fibers 1334located proximal to lens 1332. Light passing through lens 1332 passesthrough fiber optic fibers 1334. Thus, light emitted by the endoscope istransmitted by fiber optic fibers 1334 through lens 1332 to illuminate afield of view. The light is reflected from anatomical regions and enterslend 1332. Light entering lens 1332 is transmitted by fiber optic fibers1334 to socket 1328. Thereafter, the light enters the endoscope attachedto socket 1328 to provide the user an image of the target anatomy to bevisualized. Fiber optic fibers 1334 of periscope 1326 are arranged suchthat they are substantially aligned with the fiber optic fibers of theendoscope attached to socket 1328. In one embodiment, a part of fiberoptic fibers 1334 of periscope 1326 are designed to transmit lightemitted from the endoscope to illuminate the field of view. Another partof fiber optic fibers 1334 of periscope 1326 are designed to transmitlight reflected from anatomical structures to the endoscope. In oneembodiment, periscope 1326 further comprises one or more intermediatelenses 1336 located between the ends of adjacent bundles of fiber opticfibers 1334 as shown in FIG. 13C. In one embodiment of a method of usingdevice guide 1320, the target region around the anatomical obstructionis visualized by an endoscope that is attached to periscope 1326.Thereafter, one or more diagnostic, therapeutic or introducing devicesare introduced into the target region through elongate body 1322.

FIGS. 13D and 13E show the various steps of an embodiment of a method toendoscopically visualize a target region around an anatomicalobstruction using a device guide comprising a periscope. In this methodembodiment, device guide 1320 shown in FIG. 13A is used as an example ofa device guide comprising a periscope. In FIG. 13D, a user attempts tovisualize a target anatomical region around an anatomical obstructionusing an endoscope 1340. In one embodiment, the target anatomical regionis the ostium of a maxillary sinus and the anatomical obstruction is anasal turbinate. If the attempt is unsuccessful, the method proceeds tothe step shown in FIG. 13E. In FIG. 13E, the user fits the distal tip ofendoscope 1340 into the proximal end of periscope 1306. This enables theuser to visualize the anatomy around the anatomical obstruction.Thereafter, one or more devices may be introduced through device guide1320 into the anatomy.

The various devices described or incorporated herein may include one ormore optical marker(s). Such optical marker(s) may be used for examplefor optically determining the relative location of the balloon of theballoon catheter with respect to the distal end of a guide catheterthrough which the balloon catheter is introduced. Such optical marker(s)may enable a user to determine the location of the balloon of theballoon catheter with respect to the distal end of a guide catheterwithout using methods like fluoroscopy that used ionizing radiation. Ifthe balloon is too close to the distal end of the guide catheter, thereis a risk that the balloon may be inflated by a user while it is insidethe guide catheter. If the balloon is too far from the distal end of theguide catheter, the guide catheter may not provide adequate support tothe balloon catheter. Thus, the balloon of the balloon catheter shouldbe located at an optimal distance with respect to the distal end of theguide catheter. In one embodiment, the optimal distance is ensured byproviding an optical marker on the proximal region of the ballooncatheter. The balloon catheter is inserted through a guide catheter suchthat the distal region of the balloon catheter emerges out of the distalend of the guide catheter. The location of the optical marker relativeto the proximal region of the guide catheter is used to determine therelative location of the balloon of the balloon catheter with respect tothe distal end of the guide catheter. In another embodiment, the optimaldistance is ensured by providing an optical marker on the distal regionof the balloon catheter. The balloon catheter is inserted through aguide catheter such that the distal region of the balloon catheteremerges out of the distal end of the guide catheter. The location ofeach optical marker may be tracked by an endoscope inserted in theanatomy. The location of the optical marker relative to the distal endof the guide catheter is used to determine the relative location of theballoon of the balloon catheter with respect to the distal end of theguide catheter.

Similar optical markers may be located on other balloon cathetersdisclosed herein. For example, an optical marker may be located on aballoon catheter proximal to a balloon on the balloon catheter. Such anoptical marker is especially useful to determine the location of theballoon with respect to a paranasal sinus ostium after the balloon hasbeen introduced in a paranasal sinus. After the balloon is insertedinside the paranasal sinus, the balloon can no longer be visually seenby an endoscope. The user can then note the location of the opticalmarker proximal to the balloon. This information enables the user todetermine the length of the balloon that is present inside the opening.This information in turn can be used by the user to accurately positionthe balloon with respect to the paranasal sinus ostium to achieveoptimal dilation of the paranasal sinus ostium.

The optical markers disclosed herein may be combined optical-radiopaquemarkers. In one embodiment, the combined optical-radiopaque markercomprises a platinum coil or marker. Preferably, the combinedoptical-radiopaque marker comprises a coating of a colored polymerincluding, but not limited to colored heat shrink polyethyleneterephthalate. The length of the combined optical-radiopaque markerranges preferably from 0.5 mm-10 mm.

While removing a balloon catheter from the anatomy, the balloon of theballoon catheter might accidentally pull anatomical structures like theuncinate and damage the anatomical structures. To prevent such damage,in the method embodiments where a balloon catheter is introduced througha guide device, the balloon catheter may be removed from the anatomyalong with the guide device. This step may be performed after ensuringthat an undesirably long distal region of the balloon catheter is notprotruding from the distal end of the guide device. The guide device mayhave a suitable attachment mechanism such as a rotating hemostasisvalve, a clip, etc. to temporarily attach the balloon catheter to theguide device. The attachment mechanism enables a user to remove theballoon catheter from the anatomy along with the guide device.

The flexible endoscopes disclosed herein may comprise one or moreendoscope lumens. In one embodiment, the endoscope lumen is a sidelumen. The side lumen is designed such that one or more diagnostic,therapeutic or access devices can be inserted in the anatomy through theside lumen under endoscopic guidance.

The guide catheters disclosed herein may comprise a bent, curved orangled distal region to allow easier access to a paranasal sinus ostium.Such guide catheters may further comprise mechanisms to introduce anendoscope along the guide catheters. For example, FIGS. 14A through 14E′show side views of embodiments of guide devices comprising bent, curvedor angled distal regions and mechanisms to introduce an endoscope alongthe guide catheters. One or more of these guide devices may be providedas a part of the system for diagnosing or treating paranasal sinuspathologies. FIG. 14A shows a side view of a first embodiment of a guidedevice comprising a substantially straight distal portion. Guide device1400 comprises an elongate tube 1402. Elongate tube 1402 may be made ofsuitable biocompatible materials such polymers e.g. Nylon, Pebax, etc.In a preferred embodiment, the material of elongate tube 1402 hasRockwell hardness in the range of about 70 R to about 110 R. In thispreferred embodiment, the distal portion is flexible enough to preventor reduce damage to the anatomy. Yet, the distal portion is rigid enoughto retain its shape as one or more devices are passed through guidedevice 1400. Furthermore, the distal portion is rigid enough to enable auser to use the distal portion to displace anatomical structures. Thedistal portion of elongate tube 1402 comprises a curved, bent or angledregion curved at an angle of less then 5 degrees. In one embodiment,distal portion of elongate tube 1402 is substantially straight. Theinner surface of elongate tube 1402 may be lined by a lubricious coatingor a tubular lubricious liner made of a suitable biocompatible materialsuch as PTFE. In one embodiment, the outer diameter of elongate tube1402 is around 0.134+/−0.005 inches. An optional dilating balloon 1403may be located on the distal region of guide device 1400. Dilatingballoon may be made of suitable biocompatible materials including, butnot limited to PET, Nylon, PVC, etc. The distal portion of elongate tube1402 comprises an atraumatic tip 1404. Atraumatic tip 1404 may be madeof suitable biocompatible materials including, but not limited to Pebax,etc. Atraumatic tip 1404 prevents or reduces damage to the anatomycaused by the distal end of guide device 1400. In one embodiment, lengthof atraumatic tip 1404 is 0.08+/−0.04 inches and the material of tip1404 has Shore Durometer hardness in the range of about 35 D to about 72D. Guide device 1400 further comprises a hypotube 1406. Hypotube 1406may be made of suitable biocompatible materials such as stainless steel304, titanium. Nickel-titanium alloy (e.g., Nitinol), polymers such asNylon etc. In one embodiment, the outer diameter of hypotube 1406 is0.154+/−0.005 inches. In one embodiment of a method of constructingguide device 1400, a stainless steel hypotube 1406 is bonded to anelongate tube 1402 such as a Nylon elongate tube 1402 to increase thestrength of elongate tube 1402. In one embodiment, hypotube 1406 is heatbonded to elongate tube 1402. One or more openings, perforations orholes may be located on hypotube 1406 to enable material of elongatetube 1402 to melt into the one or more openings, perforations or holes.When the melted material of elongate tube 1402 solidifies, an additionalmechanical bonding is created between hypotube 1406 and elongate tube1402. Guide device 1400 further comprises an endoscope introducingmechanism for introducing an endoscope EN. In the embodiment shown inFIG. 14A, the endoscope introducing mechanism comprises a side lumen1407 through which a suitable flexible endoscope EN can be introduced inthe anatomy. The proximal end of guide device 1400 comprises a hub 1408.In one embodiment, hub 1408 is a female luer hub. Hub 1408 may havewings 1409 to enable a user to turn guide device 1400. In oneembodiment, the axial length of guide device 1400 is 5+/−0.25 inches. Inone embodiment, the inner diameter of guide device 1400 is around 0.1inches. The distal portion of guide device 1400 may comprise aradiopaque marker. In one embodiment, the radiopaque marker is aplatinum/iridium marker band. The guide device design shown in FIG. 14Ais especially suited for trans-nasal access of the sphenoid sinuses.

FIG. 14B shows a side view of a first embodiment of a guide devicecomprising a bent, angled or curved distal portion. Guide device 1410comprises an elongate tube 1412. Elongate tube 1412 may be made ofsuitable biocompatible materials such polymers e.g. Nylon, Pebax, etc.Elongate tube 1412 comprises a substantially straight proximal portionenclosed by a hypotube and a distal portion comprising a curved, bent orangled region. The angle of the curved, bent or angled region of thedistal portion can range from 5 degrees to 45 degrees. In thisembodiment, distal portion of elongate tube 1412 is bent by an angle ofaround 30 degrees. The inner surface of elongate tube 1412 may be linedby a lubricious coating or a tubular lubricious liner made of a suitablebiocompatible material such as PTFE. In one embodiment, the outerdiameter of elongate tube 1412 is around 0.134+/−0.005 inches. Anoptional dilating balloon 1413 may be located on the distal region ofguide device 1410. Dilating balloon may be made of suitablebiocompatible materials including, but not limited to PET, Nylon, PVC,etc. The distal portion of elongate tube 1412 comprises an atraumatictip 1414. Atraumatic tip 1414 may be made of suitable biocompatiblematerials including, but not limited to Pebax, etc. Atraumatic tip 1414prevents or reduces damage to the anatomy caused by the distal end ofguide device 1410. In one embodiment, length of atraumatic tip 1414 is0.08+/−0.04 inches. Guide device 1410 further comprises a hypotube 1416covering the proximal portion of elongate tube 1412. Hypotube 1416 maybe made of suitable biocompatible materials such as stainless steel 304,titanium, Nickel-titanium alloy (e.g., Nitinol), polymers such as Nylonetc. In one embodiment, the outer diameter of hypotube 1416 is0.154+/−0.005 inches. In one embodiment of a method of constructingguide device 1410, a stainless steel hypotube 1416 is bonded to a Nylonelongate tube 1412. Guide device 1410 further comprises an endoscopeintroducing mechanism for introducing an endoscope EN. In the embodimentshown in FIG. 14B, the endoscope introducing mechanism comprises a sidelumen 1417 through which a suitable flexible endoscope EN can beintroduced in the anatomy. The proximal end of guide device 1410comprises a hub 1418. In one embodiment, hub 1418 is a female luer hub.Hub 1418 may have wings 1419 to enable a user to turn guide device 1410.Wings 1419 may be aligned in the plane of the curve of the distal tip asan indicator of the position and orientation of the distal tip in theanatomy. In one embodiment, the axial length of guide device 1410 is5+/−0.25 inches. In one embodiment, the inner diameter of guide device1410 is around 0.1 inches. The distal portion of guide device 1410 maycomprise a radiopaque marker. In one embodiment, the radiopaque markeris a platinum/iridium marker band. FIG. 14B′ shows an enlarged view ofthe distal portion of the guide device in FIG. 14B. FIG. 14B′ showselongated tube 1412 enclosed by hypotube 1416. Distal end of elongatedtube 1412 comprises atraumatic tip 1414. Several parameters definedhereafter characterize the design of the distal portion of guide device1410. The width of the distal end of guide device 1410 is called W asshown. The length measured from the proximal-most point on the distalcurved portion of elongate tube 1412 to the distal-most part of thedistal tip is called L1. L1 is measured along the linear direction ofthe straight proximal portion of guide device 1410 as shown in FIG.14B′. The length of the straight region of elongate tube 1412 from thedistal end of t hypotube 1416 till the proximal most point on the curvedregion of the distal portion is called L2. In one particular embodiment.W is 0.34+/−0.08 inches, L1 is 0.46+/−0.08 inches, L2 is 0 to 2 inchesand the radius of curvature of the distal curved region of elongate tube1412 is 0.180 inches. The guide device design shown in FIGS. 14B and14B′ is especially suited for trans-nasal access of the sphenoidsinuses.

FIG. 14C shows a side view of a second embodiment of a guide devicecomprising a bent, angled or curved distal portion. The design of guidedevice 1420 is similar to the design of guide device 1410. Guide device1420 comprises an elongate tube 1422. The distal portion of elongatetube 1422 comprises a curved, bent or angled region curved at an angleranging from 30 degrees to 140 degrees. In this embodiment, distalportion of elongate tube 1422 is bent by an angle of around 70 degrees.An optional dilating balloon 1423 may be located on the distal region ofguide device 1420. Dilating balloon may be made of suitablebiocompatible materials including, but not limited to PET, Nylon, PVC,etc. The distal portion of elongate tube 1422 comprises an atraumatictip 1424. Guide device 1420 further comprises a hypotube 1426. Guidedevice 1420 further comprises an endoscope introducing mechanism forintroducing an endoscope EN. In the embodiment shown in FIG. 14C, theendoscope introducing mechanism comprises a side lumen 1427 throughwhich a suitable flexible endoscope EN can be introduced in the anatomy.The proximal end of guide device 1420 comprises a hub 1428. In oneembodiment, hub 1428 is a female luer hub. Hub 1428 may have wings 1429to enable a user to turn guide device 1420. FIG. 14C′ shows an enlargedview of the distal portion of the guide device in FIG. 14C. FIG. 14C′shows elongated tube 1422 enclosed by hypotube 1426. Distal end ofelongated tube 1422 comprises atraumatic tip 1424. In one particularembodiment, W is 0.45+/−0.08 inches, L1 is 0.32+/−0.08 inches, L2 is 0to 2 inches and the radius of curvature of the distal curved region ofelongate tube 1422 is 0.180 inches. The guide device design shown inFIGS. 14C and 14C′ is especially suited for trans-nasal access of thefrontal sinuses.

FIG. 14D shows a side view of a second embodiment of a guide devicecomprising a bent, angled or curved distal portion. The design of guidedevice 1430 is similar to the design of guide device 1410. Guide device1430 comprises an elongate tube 1432. The distal portion of elongatetube 1432 comprises a curved, bent or angled region curved at an angleranging from 70 degrees to 135 degrees. In this embodiment, distalportion of elongate tube 1432 is bent by an angle of around 90 degrees.An optional dilating balloon 1433 may be located on the distal region ofguide device 1430. Dilating balloon may be made of suitablebiocompatible materials including, but not limited to PET, Nylon, PVC,etc. The distal portion of elongate tube 1432 comprises an atraumatictip 1434. Guide device 1430 further comprises a hypotube 1436. Guidedevice 1430 further comprises an endoscope introducing mechanism forintroducing an endoscope EN. In the embodiment shown in FIG. 14D, theendoscope introducing mechanism comprises a side lumen 1437 throughwhich a suitable flexible endoscope EN can be introduced in the anatomy.The proximal end of guide device 1430 comprises a hub 1438. In oneembodiment, hub 1438 is a female luer hub. Hub 1438 may have wings 1439to enable a user to turn guide device 1430. FIG. 14D′ shows an enlargedview of the distal portion of the guide device in FIG. 14D. FIG. 14D′shows elongated tube 1432 enclosed by hypotube 1436. Distal end ofelongated tube 1432 comprises atraumatic tip 1434. In one particularembodiment, W is 0.39+/−0.080 inches, L1 is 0.25+/−0.08 inches, L2 is 0to 2 inches and the radius of curvature of the distal curved region ofelongate tube 1432 is 0.180 inches. W may be as small as 5 mm with acorresponding reduction in the radius of curvature of the distal curvedregion of elongate tube 1432. The guide device design shown in FIGS. 14Dand 14D′ is especially suited for trans-nasal access of the maxillarysinuses.

FIG. 14E shows a side view of a third embodiment of a guide devicecomprising a bent, angled or curved distal portion. The design of guidedevice 1440 is similar to the design of guide device 1410. Guide device1440 comprises an elongate tube 1442. The distal portion of elongatetube 1442 comprises a curved, bent or angled region curved at an angleranging from 140 degrees to 120 degrees. In this embodiment, distalportion of elongate tube 1442 is bent by an angle of around 110 degrees.An optional dilating balloon 1443 may be located on the distal region ofguide device 1440. Dilating balloon may be made of suitablebiocompatible materials including, but not limited to PET, Nylon, PVC,etc. The distal portion of elongate tube 1442 comprises an atraumatictip 1444. Guide device 1440 further comprises a hypotube 1446. Guidedevice 1440 further comprises an endoscope introducing mechanism forintroducing an endoscope EN. In the embodiment shown in FIG. 14E, theendoscope introducing mechanism comprises a side lumen 1447 throughwhich a suitable flexible endoscope EN can be introduced in the anatomy.The proximal end of guide device 1440 comprises a hub 1448. In oneembodiment, hub 1448 is a female luer hub. Hub 1448 may have wings 1449to enable a user to turn guide device 1440. FIG. 14E′ shows an enlargedview of the distal portion of the guide device in FIG. 14E. FIG. 14E′shows elongated tube 1442 enclosed by hypotube 1446. Distal end ofelongated tube 1442 comprises atraumatic tip 1444. In one particularembodiment, W is 0.46+/−0.08 inches, L1 is 0.25+/−0.08 inches, L2 is 0to 0.5 inches and the radius of curvature of the distal curved region ofelongate tube 1442 is 0.180 inches. L1 and W may be smaller than0.25+/−0.08 inches and 0.46+/−0.08 inches respectively. The guide devicedesign shown in FIGS. 14E and 14E′ is especially suited for trans-nasalaccess of the maxillary sinuses.

FIG. 15A shows a cross sectional view of a first embodiment of a ballooncatheter comprising a short guidewire lumen. Balloon catheter 1500comprises a hollow, elongate shaft 1502. Elongate shaft 1502 can be madeof suitable biocompatible materials including, but not limited to metalse.g. stainless steel, titanium, Nickel-titanium alloy (e.g., Nitinol),etc.; polymers e.g. Nylon, Pebax, PEEK, polyethylene, etc. The proximalend of elongate shaft 1502 is connected to a suitable inflation port1504 such as a female luer lock. In one embodiment, balloon catheter1500 further comprises an elongate hypotube 1506 located betweenelongate shaft 1502 and inflation port 1504. The distal end of elongateshaft 1504 is attached to the proximal end of a balloon 1508 such thatinflation port 1504 is in fluid communication with balloon 1508. Balloon1508 can be made of suitable biocompatible materials including, but notlimited to PET, Nylon, PVC, polyethylene, polyurethane, Pebax, etc.Balloon 1508 also encloses a guidewire shaft 1510 enclosing a guidewirelumen 1512. The length of guidewire shaft 1510 is less then the lengthof elongate shaft 1502. In one embodiment, the length of guidewire shaft1510 ranges from 5-12 cm. The proximal region of guidewire shaft 1512 isconnected sideways to elongate shaft 1502 such that guidewire shaft 1512is substantially parallel to elongate shaft 1502. The proximal end ofguidewire shaft 1512 is located in a region proximal to balloon 1508.The distal end of guidewire lumen 1512 is located in a region distal toballoon 1508. Guidewire shaft 1512 enables balloon catheter 1500 to beintroduced over a suitable guidewire into an anatomical region. In oneembodiment, the length of balloon catheter 1500 from the distal end ofinflation port 1504 till the distal end of guidewire shaft 1510 isaround 30 cm. In one embodiment, guidewire shaft 1512 comprises anavigational marker such as a radiopaque marker band 1514. Similarnavigational markers may be present on other embodiments of ballooncatheters disclosed herein and in the patent applications incorporatedherein by reference. In one embodiment, two navigational markers arepresent on the balloon catheter shaft corresponding to the proximal anddistal end respectively of the working length of the balloon. In anotherembodiment, a navigational marker is present on the balloon shaftcorresponding to the proximal end of the balloon. Such a navigationalmarker is especially useful to determine the position of the proximalend of the balloon relative to the distal end of an introducing catheterwhen the balloon catheter is introduced through the introducingcatheter. The user tracks the position of the navigational markerrelative to the distal end of the introducing catheter to ensure thatthe balloon is not inflated within the introducing catheter. Examples ofsuch a navigational marker include, but are not limited to a radiopaquemarker band for fluoroscopic visualization, a colored ring forendoscopic visualization, etc.

FIGS. 16-16C show a balloon catheter 1600 constructed of a first shaft1602 having a first lumen 1604, a second shaft 1612 and third shaftssuch that a short lumen (e.g., a rapid exchange guidewire lumen) extendsthrough the balloon. Balloon catheter 1600 comprises a hollow, firstelongate shaft 1602. First elongate shaft 1602 can be made of suitablebiocompatible materials including, but not limited to metals e.g.stainless steel, titanium, Nickel-titanium alloy (e.g., Nitinol), etc.;polymers e.g. Nylon, Pebax, PEEK, polyethylene, etc. First elongateshaft 1602 comprises a first lumen 1604. The proximal end of elongateshaft 1602 is connected to a suitable hub such as a female luer lock1606 which is in fluid communication with first lumen 1604. A hypotube1608 may be provided between female luer lock 1606 and first elongateshaft 1602. The distal end of first lumen 1604 is in fluid communicationwith a balloon 1610 located on the distal region of first elongate shaft1602. Thus, first lumen 1604 can be used to inflate balloon 1610.Balloon 1610 can be made of suitable biocompatible materials including,but not limited to PET, Nylon, PVC, polyethylene, polyurethane, Pebax,etc. The distal region of first elongate shaft 1602 is enclosed by asecond elongate shaft 1612. Second elongate shaft 1612 further enclosesa region of a third elongate shaft 1614 comprising a lumen. The proximalend of the lumen of third elongate shaft 1614 is located proximal toballoon 1610. The distal end of the lumen of third elongate shaft 1614is located distal to balloon 1610. In one embodiment, the length ofthird elongate shaft 1614 may range from 5-12 cm. Third elongate shaft1614 enables balloon catheter 1600 to be introduced over a suitableguidewire GW into an anatomical region. Third elongate shaft 1614 mayfurther comprise a navigational marker such as a radiopaque marker band1616 made of suitable radiopaque materials such as platinum-iridiumalloys, etc. In one embodiment, the length of balloon catheter 1600 fromthe proximal end of female luer lock 1606 till the distal end of thirdelongate shaft 1614 is around 30 cm.

FIG. 16A is a cross sectional view through line 16A-16A of FIG. 16. FIG.16A shows a cross sectional view of elongate shaft 1602 comprising firstlumen 1604. FIG. 16B is a cross sectional view through line 16B-16B ofFIG. 16. FIG. 16B shows second elongate shaft 1612 enclosing firstelongate shaft 1602 and third elongate shaft 1614. FIG. 16C is a crosssectional view through line 16C-16C of FIG. 16. FIG. 16C shows secondelongate shaft 1612 enclosing third elongate shaft 1614.

FIG. 17 shows a balloon catheter 1700 that comprises an elongate shaft1702 having a mandrel 1712 positioned therein. The elongate shaft 1702may be made of suitable biocompatible materials including, but notlimited to polyethylene, Pebax, Nylon, etc. Elongate shaft 1702 enclosesa lumen. The proximal end of elongate shaft 1702 comprises a suitablehub 1704. In one embodiment, hub 1704 is a female luer lock. A strainrelief tubing 1706 may be present between hub 1704 and elongate shaft1702. The distal region of elongate shaft 1702 comprises a balloon 1708.Balloon 1708 may be made of suitable biocompatible materials including,but not limited to PET, Nylon, PVC, polyethylene, polyurethane, Pebax,etc. The region of elongate shaft 1702 enclosed by balloon 1708comprises an opening 1710 that provides fluid communication between thelumen of elongate shaft 1702 and balloon 1708. The lumen of elongateshaft 1702 can thus be used to inflate balloon 1708. Elongate shaft 1702may further comprise a navigational marker such as a radiopaque markerband 1711 located on the distal region of elongate shaft 1702. A mandrel1712 is located in lumen 1703 such that a distal region of mandrel 1712emerges out of the distal end of elongate shaft 1702. The distal end ofelongate shaft 1702 is connected to mandrel 1712 by a fluid-tight seal.FIG. 17A shows a cross sectional view of balloon catheter 1700 of FIG.17 through plane 17A-17A. FIG. 17A shows elongate shaft 1702 enclosing alumen and mandrel 1712 located in the lumen.

FIG. 17B shows an enlarged perspective view of the mandrel in FIG. 8F.Mandrel 1712 comprises a proximal region 1714, a tapering region 1716, adistal region 1718 and a distal tip 1720. Proximal region 1714 may havean outer diameter ranging from 0.005 inches to 0.12 inches. Distal tip1720 emerges out of the distal end of elongate shaft 1702 and can beused to navigate balloon catheter 1700 through the anatomy or to insertballoon catheter 1700 through an anatomical opening or passageway.Distal tip 1720 further comprises a coil 1722 coiled around a region ofor around the entire length of distal tip 1720. Coil 1722 can be made ofsuitable materials including, but not limited to platinum, stainlesssteel, nickel-titanium alloys such as Nitinol, etc. In a particularembodiment, the distance from the proximal end of tapering region 1716to the distal end of distal region 1718 ranges from 2 to 6 cm and thelength of distal tip ranges from 1 to 3 cm. Mandrel 1712 may be made ofsuitable biocompatible materials including, but not limited to stainlesssteel, Nickel-titanium alloy (e.g., Nitinol), etc.

FIG. 18 shows a balloon catheter 1800 comprising a shaft 1802 having alumen 1804 with a side slit 1809 and a balloon 1810 or other expandabledilator. Elongate shaft 1802 can be made of suitable biocompatiblematerials including, but not limited to metals e.g. stainless steel,titanium, Nickel-titanium alloy (e.g., Nitinol), etc.; polymers e.g.Nylon, Pebax, PEEK, polyethylene, etc. In the particular example shown,the elongate shaft 1802 comprises a first lumen 1804 useable as aguidewire lumen and and a second lumen 1806 useable to inflate theballoon 1810. The proximal end of first lumen 1804 may be occludedproximal to a slit 1809. The proximal region of elongate shaft 1802 maybe connected to a hub 1808 which is in fluid communication with secondlumen 1806. In this example, hub 1808 is a female luer lock. The slit1809 extends along one side of the shaft 1802 proximal to the balloon1810 and allows a guidewire to be pulled laterally out of the firstlumen 1804 and through the slit 1809. This enables balloon catheter 1800to be advanced or withdrawn over a suitable elongate devices such as aguidewire such that the a portion of the suitable elongate device entersballoon catheter 1800 from the distal end of first lumen 1804 and exitsout of balloon catheter 1800 through slit 1807. A balloon 1810 islocated on the distal region of elongate shaft 1802. Balloon 1810 may bemade of suitable biocompatible materials including, but not limited toPET, Nylon, PVC, polyethylene, polyurethane, Pebax, etc. A navigationalmarker 1812 such as a radiopaque marker band may be located on theregion of elongate shaft 1802 enclosed by balloon 1810. The distal endof first lumen 1804 terminates in a region distal to balloon 1810. Thedistal end of second lumen 1806 is in fluid communication with balloon1810 such that second lumen 1806 can be used to inflate or deflateballoon 1810. FIG. 18A shows a cross sectional view of the ballooncatheter in FIG. 18 through the plane 18A-18A. FIG. 18A shows a crosssection of elongate sheath 1802 showing first lumen 1804, second lumen1806 and slit 1807. FIG. 18B shows a cross sectional view of the ballooncatheter in FIG. 18 through the plane 18B-18B. FIG. 18B shows a crosssection of elongate sheath 1802 showing first lumen 1804.

FIGS. 19-19C show a catheter device 1900 comprising an elongate cathetershaft 1902, a balloon 1906 or other expandable dilator mounted onelongate shaft 1902 and apparatus such as capacitance plates 1908, 1910located on opposite sides of the balloon or other dilator fordetermining its diameter. In the example shown, the elongate shaft 1902may be made of suitable biocompatible materials including, but notlimited to metals e.g. stainless steel, titanium, Nickel-titanium alloy(e.g., Nitinol), etc.; polymers e.g. Nylon, Pebax, PEEK, polyethylene,etc. Elongate shaft 1902 may comprise a guidewire lumen 1904 to enableballoon catheter 1900 to be advanced or withdrawn over a suitableguidewire. The distal region of balloon catheter 1900 comprises aballoon 1906 made of suitable biocompatible materials including, but notlimited to PET, Nylon, PVC, polyurethane, etc. Balloon 1906 may beinflated or deflated by introducing or withdrawing fluid through aballoon inflation lumen present in elongate shaft 1902. Balloon 1906further comprises a first capacitance plate 1908 and a secondcapacitance plate 1910. First capacitance plate 1908 and secondcapacitance plate 1910 may be made of suitable biocompatible metalssheets. First capacitance plate 1908 and second capacitance plate 1910are electrically insulated from balloon 1906 and the fluid used toinflate balloon 1906. First capacitance plate 1908 is connected by afirst insulated wire 1912 to a source of electrical supply. Secondcapacitance plate 1910 is connected by a second insulated wire 1914 tothe source of electrical supply such that an electric field is generatedbetween first capacitance plate 1908 and second capacitance plate 1910.This causes balloon 1906 to behave like a capacitor with a capacitancedepending on various properties such as distance between firstcapacitance plate 1908 and second capacitance plate 1910, type ofinflation fluid, size of first capacitance plate 1908 and secondcapacitance plate 1910, etc. As balloon 1906 is inflated or deflated,the distance between first capacitance plate 1908 and second capacitanceplate 1910 changes. This in turn changes the capacitance. The change incapacitance can be measured through first insulated wire 1912 and secondinsulated wire 1914 to non-invasively measure the degree of inflation ofballoon 1906. Using this method, the degree of inflation of balloon 1906may be measured without the use of ionizing radiation. First insulatedwire 1912 and second insulated wire 1914 may be further insulated fromthe surroundings by a layer of insulating covering 1916. Insulatingcovering 1916 covers first insulated wire 1912, second insulated wire1914 and elongate shaft 1902. FIG. 19A shows a side view of the ballooncatheter in FIG. 19. FIG. 19A shows balloon catheter 1900 comprisingelongate shaft 1902, balloon 1906, first capacitance plate 1908 andfirst insulated wire 1912 connected to first capacitance plate 1908.FIGS. 19B and 19C show cross sectional views of the balloon catheter inFIG. 19 through planes 19B-19B and 19C-19C respectively. FIG. 19B showsa cross section of shaft 1902 comprising guidewire lumen 1904 and aballoon inflation lumen 1918. In this embodiment, balloon inflationlumen 1918 is annular and is coaxial to guidewire lumen 1904. Shaft 1902further comprises first insulated wire 1912 and second insulated wire1914 covered by insulating covering 1916. FIG. 19C shows a cross sectionthrough balloon 1906 showing shaft 1902 enclosing guidewire lumen 1904.Also shows are first capacitance plate 1908 and second capacitance plate1910 located on balloon 1906.

FIGS. 20-20C show a balloon catheter 2000 comprising an elongatecatheter shaft 2002, a balloon 2006 or other expandable dilator mountedon the catheter shaft 2002 and apparatus for determining the diameter ofthe balloon 2006, such as capacitance plates 2008, 2010, one of which islocated on the wall of the balloon 2006 and the other of which islocated on a portion of the catheter shaft 2016 that extends through theballoon 2006. The elongate shaft 2002 can be made of suitablebiocompatible materials including, but not limited to metals e.g.stainless steel, titanium, Nickel-titanium alloy (e.g., Nitinol), etc.;polymers e.g. Nylon, Pebax, PEEK, polyethylene, etc. Elongate shaft 2002may comprise a guidewire lumen 2004 to enable balloon catheter 2000 tobe advanced or withdrawn over a suitable guidewire. Balloon 2006 made ofsuitable biocompatible materials including, but not limited to PET,Nylon, PVC, polyethylene, polyurethane, Pebax, etc. Balloon 2006 may beinflated or deflated by introducing or withdrawing fluid through aballoon inflation lumen present in elongate shaft 2002. Firstcapacitance plate 2008 and second capacitance plate 2010 areelectrically insulated from balloon 2006 and the fluid used to inflateballoon 2006. First capacitance plate 2008 is connected by a firstinsulated wire 2012 to a source of electrical supply. Second capacitanceplate 2010 connected by a second insulated wire 2014 to the source ofelectrical supply such that an electric field is generated between firstcapacitance plate 2008 and second capacitance plate 2010. This causesballoon 2006 to behave like a capacitor with a capacitance depending onvarious properties such as distance between first capacitance plate 2008and second capacitance plate 2010, type of inflation fluid, size offirst capacitance plate 2008 and second capacitance plate 2010, etc. Asballoon 2006 is inflated or deflated, the distance between firstcapacitance plate 2008 and second capacitance plate 2010 changes. Thisin turn changes the capacitance. The change in capacitance can bemeasured through first insulated wire 2012 and second insulated wire2014 to non-invasively measure the degree of inflation of balloon 2006.Using this method, the degree of inflation of balloon 2006 may bemeasured without the use of ionizing radiation. First insulated wire2012 and second insulated wire 2014 may be further insulated from thesurroundings by a layer of insulating covering 2016. Insulating covering2016 covers first insulated wire 2012, second insulated wire 2014 andelongate shaft 2002. FIG. 20A shows a side view of the balloon catheterin FIG. 20. FIG. 20A shows balloon catheter 2000 comprising elongateshaft 2002, balloon 2006, first capacitance plate 2008 and firstinsulated wire 2012 connected to first capacitance plate 2008. FIGS. 20Band 20C show cross sectional views of the balloon catheter in FIG. 20Athrough planes 20B-20B and 20C-20C respectively. FIG. 20B shows a crosssection of shaft 2002 comprising guidewire lumen 2004 and a ballooninflation lumen 2018. In this embodiment, balloon inflation lumen 2018is annular and is coaxial to guidewire lumen 2004. Shaft 2002 furthercomprises first insulated wire 2012 and second insulated wire 2014covered by insulating covering 2016. FIG. 20C shows a cross sectionthrough balloon 2006 showing shaft 2002 enclosing guidewire lumen 2004.Also shows are first capacitance plate 2008 and second capacitance plate2010 located on balloon 2006.

In an alternate embodiment, a balloon catheter comprises a firstcapacitance plate located on or within the balloon material; a secondcapacitance plate located on or within the balloon material and one ormore shaft plates located on or within the balloon shaft. A usermeasures a first capacitance between the first capacitance plate and theone or more shaft plates. Also, the user measures a second capacitancebetween the second capacitance plate and the one or more shaft plates.The first capacitance and the second capacitance may be used to measurethe degree of balloon inflation and also to measure the evenness ofballoon inflation.

Any of the balloon catheters comprising capacitance measuring meansdisclosed herein may comprise a temperature sensor to measure thetemperature of the inflation fluid. This is useful in cases where thedielectric constant of the inflation fluid varies significantly withtemperature.

FIG. 21 shows a balloon catheter 2100 having a proximal shaft 2104, amalleable distal shaft 2102, an expandable dilator such as a balloon2106 and, optionally, a distal guide projection such as a wire 2108.This balloon catheter device is useable for a variety of applicationsincluding, but not limited to the diagnosis and treatment of certainEthmoid sinus pathologies. The malleable distal region 2102 may be madeof suitable biocompatible materials including, but not limited tostainless steel, Nickel-titanium alloy (e.g., Nitinol), polymer/metalcomposites, etc. Malleable distal region 2102 may be deformed or shapedby a user during a procedure to allow for easier access and navigationthrough a target anatomy. The proximal region of the catheter shaft maycomprise a substantially non-malleable proximal region 2104. Malleabledistal region 2102 comprises a balloon 2106. Balloon 2106 may be made ofsuitable biocompatible materials including, but not limited to PET,Nylon, PE etc. The length of balloon 2106 ranges from 3 to 40 mm and theinflated diameter of balloon 2106 ranges from 3 to 10 mm. In oneembodiment adapted to treat Ethmoid sinuses, the length of balloon 2106ranges from 3 to 10 mm and the inflated diameter of balloon 2106 rangesfrom 3 to 6 mm. Balloon catheter 2100 further comprises a navigationmechanism. In one embodiment, the navigation mechanism comprises alength of wire 2108 fixed to the distal end of balloon catheter 2100.The length of wire 2108 may range from 1 to 3 cm. In an alternateembodiment, the navigation mechanism is a rapid exchange lumen throughthe catheter shaft. In one embodiment, the length of rapid exchangelumen is more then half the total catheter length. For example, in aballoon catheter of total length around 20 cm, the length of the rapidexchange lumen may be about 10 cm. In a balloon catheter of total lengtharound 15 cm, the length of the rapid exchange lumen may be about 13.5to 10 cm. In an alternate embodiment, the navigation mechanism is anend-to-end lumen through the catheter shaft to allow balloon catheter2100 to be introduced over a guidewire.

FIG. 22 shows balloon catheter 2200 having a proximal shaft 2202, aflexible distal shaft 2204, an expandable dilator such as a balloon 2206and, optionally, a distal guide projection such as a wire 2208. Thisballoon catheter device 2200 is useable to perform a variety ofdiagnostic or therapeutic procedures, some of which are disclosedherein. Such a balloon catheter design comprising a flexible distalshaft is especially suitable for diagnosing or treating pathologiesincluding, but not limited to Ethmoid sinus pathologies. The proximalregion 2202 of this catheter is substantially stiff and the distalregion 2204 is more flexible than the proximal region 2202. Flexibledistal region 2204 may be made of suitable biocompatible materialsincluding, but not limited to Nylon, Pebax, HDPE, LDPE, Polyimide,polymer/metal composites, braided materials, etc. Flexible distal region2204 is deformed during a procedure to allow for easier access andnavigation through a target anatomy. Flexible distal region 2204comprises a balloon 2206. Balloon 2206 may be made of suitablebiocompatible materials including, but not limited to PET, Nylon, PEetc. The length of balloon 2206 ranges from 3 to 40 mm and the inflateddiameter of balloon 2206 ranges from 3 to 10 mm. In one embodimentadapted to treat Ethmoid sinuses, the length of balloon 2206 ranges from3 to 10 mm and the inflated diameter of balloon 2206 ranges from 3 to 6mm. Balloon catheter 2200 further comprises a navigation mechanism. Inone embodiment, the navigation mechanism comprises a length of wire 2208fixed to the distal end of balloon catheter 2200. The length of wire2208 may range from 1 to 3 cm. In an alternate embodiment, thenavigation mechanism is a rapid exchange lumen through the cathetershaft. The length of the rapid exchange lumen may range from 1 cm to 15cm. In one embodiment, the length of rapid exchange lumen is more thenhalf the total catheter length. For example, in a balloon catheter oftotal length around 20 cm, the length of the rapid exchange lumen may beabout 10 cm. In a balloon catheter of total length around 15 cm, thelength of the rapid exchange lumen may be about 13.5 to 10 cm. In analternate embodiment, the navigation mechanism is an end-to-end lumenthrough the catheter shaft to allow balloon catheter 2200 to beintroduced over a guidewire.

The balloon catheters disclosed herein and in the patent applicationsincorporated herein by reference may comprise a balloon of a workinglength adapted for dilating a particular region of the anatomy. Forexample, a balloon catheter comprising a balloon of working lengthranging from 10-40 mm may be used for treating a disease of the frontalsinuses. Ideally, the balloon comprises a working length ranging from20-30 mm. The inflated diameter of such balloons may range from 4-10 mm.In another example, a balloon catheter comprising a balloon of workinglength ranging from 6-10 mm may be used for treating a disease of themaxillary sinuses. In another example, a balloon catheter comprising aballoon of working length ranging from 3-10 mm may be used for dilatingthe Ethmoid sinuses.

The shafts of the balloon catheters disclosed herein and in the patentapplications incorporated herein by reference may comprise one or moreangled regions. Such balloon catheters may for example comprise anangled balloon located on an angled region of the shaft. Such ballooncatheters are especially suited for treating diseases of the maxillarysinuses.

The balloon catheters disclosed herein and in the patent applicationsincorporated herein by reference may comprise a substantially compliantballoon. Such a substantially compliant balloon may be inflated at aninflation pressure preferably less than 4 atmospheres. Such ballooncatheter may be used for example to dilate the mucosa of anatomicalregions such as passageways leading to paranasal sinuses. The step ofdilation of the mucosa may or may not include dilation of the underlyingbony structures. Such balloon catheters may also be used for sizinganatomical regions such as passageways leading to paranasal sinuses.This is performed by inflating the substantially compliant balloon by afluid comprising radiopaque contrast and observing the radiographicimage of the balloon. The step of sizing an anatomical region may beperformed before and/or after the step of dilating the anatomicalregion.

The balloon catheters disclosed herein and in the patent applicationsincorporated herein by reference may be introduced in the anatomy by avariety of manual introducing tools. Examples of such manual introducingtools include, but are not limited to forceps (e.g. giraffe forceps),pincers, tweezers, tongs, etc. Such manual introducing tools may havecurved, bent, angled or substantially straight distal regions. Forexample, a balloon catheter may be grasped in a region proximal to theballoon by a forceps and then introduced in the target anatomy.

The balloon catheters disclosed herein and in the patent applicationsincorporated herein by reference may be used to deliver heat or cold, agas, electromagnetic energy in the visible spectrum, etc.

If a balloon catheter is used for performing multiple procedures, it maybe useful to refold the balloon of the balloon catheter after eachprocedure to lower the profile of the balloon before the next procedure.

FIGS. 23-23D show a balloon folding tool 2300 useable to facilitatefolding of a balloon 2308 mounted on a balloon catheter 2306. Theballoon folding tool 2300 comprises a rigid body having a central boreor folding channel 2302 formed therein, such folding channel 2306 havinga diameter that is less than the fully inflated balloon diameter. Aplurality of side channels or parallel channels 2304 are locatedadjacent to and substantially parallel with the central bore or foldingchannel 2302 and are connected to the central bore or folding channel2302 through slots or elongate openings. The balloon 2308 is insertableinto the central bore or folding channel 2302 while in a less than fullyinflated state and, thereafter, may be fully or partially inflated tocause separate portions of the balloon 2308 to pass through the eachslot and into each side channel 2304 as seen in FIG. 23C. Thereafter,the balloon may be deflated such that each separate portion of theballoon that has passed into each side channel will form a separate wingof the deflated balloon 2308, as seen in FIG. 23D. The wings arethereafter foldable (e.g., to a creased, wrapped or furled state) toprovide a collapsed balloon shape. The number of side or parallelchannels 2304 and the resultant number of wings formed in the deflatedballoon 2308 may vary depending of the size of the balloon 2308 and themanner in which it is intended to fold or furl the balloon. In someembodiments, about 2-6 side channels 2304 will be used, providing about2-6 wings on the deflated balloon 2308.

The elongate body of the folding tool 2300 may be made of suitablebiocompatible materials including, but not limited to metals e.g.titanium, stainless steel, etc.; polymers e.g. PVC, Nylon, DELRIN®,Polycarbonate, ABS, etc. Folding tool 2300 further comprises a balloonfolding channel 2302. In one embodiment, the cross section of balloonfolding channel 2302 is substantially uniform along the length offolding tool 2300. In another embodiment, the cross sectional size ofballoon folding channel 2302 is larger at the proximal end of foldingtool 2300. In this embodiment, the cross sectional size of balloonfolding channel 2302 gradually reduces towards the distal end of foldingtool 2300 to facilitate loading a balloon catheter in balloon foldingchannel 2302. In one embodiment, balloon folding channel 2302 extendsthrough the entire length of the elongate body. In another embodiment,balloon folding channel 2302 extends through a part of the length of theelongate body. Folding tool 2300 further comprises one or more parallelchannels 2304. Parallel channels 2304 are aligned substantially parallelto balloon folding channel 2302 and overlap lengthwise to balloonfolding channel 2302 as shown in FIG. 23. FIG. 23A shows a perspectiveview of a balloon catheter 2306 comprising a balloon 2308 beingintroduced into folding tool 2300.

FIGS. 23B and 23C show an end view of the folding tool of FIG. 23showing the steps of an embodiment of a method of folding the balloon ofa balloon catheter. FIG. 23D shows a cross sectional view through afolded balloon 2308. In FIG. 23B, balloon catheter 2306 is introducedinto balloon folding channel 2302. Thereafter, in FIG. 23C, balloon 2308is partially inflated such that regions of balloon 2308 extend inparallel channels 2304. Thereafter, balloon 2308 is deflated and avacuum is created in balloon 2308. This creates one or more ridges inballoon 2308. Thereafter, folding tool 2308 is turned to obtain one ormore folds in balloon 2308. Thereafter, balloon 2308 is pulled out offolding tool 2300 to obtain a folded balloon as shown in FIG. 23D. Sucha folded balloon may thereafter be introduced in a small diameter tubeto further reduce the profile of the balloon.

In an alternate method of folding balloon 2308, balloon catheter 2306 isintroduced into balloon folding channel 2302. Thereafter, balloon 2308is partially inflated such that regions of balloon 2308 extend inparallel channels 2304. Thereafter, balloon 2308 is deflated and avacuum is created in balloon 2308. This causes one or more ridges to becreated in balloon 2308. Thereafter, balloon 2308 is pulled out offolding tool 2300. Balloon 2308 is then folded manually to obtain afolded balloon with a low profile.

Similarly, other folding tools comprising one or more folding channels,folding grooves, folding cavities, folding slits, etc. may be used forfolding one or more balloons of the balloon catheters disclosed herein.

FIG. 24 shows a balloon compressing apparatus 2400 that is useable tofacilitate folding of a balloon 2308 mounted on a catheter. This ballooncompressing apparatus 2400 generally comprises a clamping element 2404having a plurality of compression members 2416 disposed radially about acentral cavity 2417. The compression members 2416 are spaced apart fromeach other such that gaps exist between adjacent compression members2416. The compression members 2416 are moveable from non-compressingpositions where the central cavity had a first diameter to compressingpositions where the central cavity has a second diameter that is smallerthan the first diameter. The balloon 2308 is insertable into the centralcavity 2417 while the compression members are in their non-compressingpositions and, thereafter, the compression members are moveable to theircompressing positions, thereby compressing portions of the balloon 2308and causing any inflation fluid to be forced out of the balloon andcausing portions of the balloon to protrude outwardly into the gapsbetween the compression members. Such protrusion into the gaps betweencompression members 2416 forms a plurality of wings on the deflatedballoon 2308. The wings are thereafter foldable (e.g., to a creased,wrapped or furled state) to provide a collapsed balloon shape. Thenumber of gaps and the resultant number of wings formed in the deflatedballoon 2306 may vary depending of the size of the balloon 2308 and themanner in which it is intended to fold or furl the balloon. In someembodiments, about 2-6 side gaps will be used, providing about 2-6 wingson the deflated balloon 2308.

In the particular example shown in the figures, folding tool 2400comprises a screw cap 2402 that encloses a clamping element 2404. Thedistal end of clamping element 2404 and the distal end of screw cap 2402are in contact with a distal handle 2406. Clamping element 2404, screwcap 2402 and distal handle 2406 may be made of suitable biocompatiblematerials including, but not limited to metals e.g. stainless steel,titanium, etc.; polymers e.g. PVC, Polycarbonate, Delrin®, Nylon, ABS,etc, FIG. 24A shows an exploded view of the various components of theballoon folding tool of FIG. 24. Distal handle 2406 comprises anelongate body comprising screw threads 2408 located on the proximal endof the elongate body. Distal handle 2406 may comprise a lumen 2410. Theouter surface of distal handle 2406 may be roughened to increase thegrip of a user on distal handle 2406. In one embodiment, outer surfaceof distal handle 2406 is roughened by knurling. Screw cap 2402 comprisesa lumen 2412. The inner surface of screw cap 2402 comprises screwthreads that screw over screw threads 2408 of distal handle 2406. Theouter surface of screw cap 2402 may be roughened to increase the grip ofa user on screw cap 2402. In one embodiment, outer surface of screw cap2402 is roughened by knurling. Clamping element 2404 is enclosed byscrew cap 2402 and distal handle 2406. Clamping element 2404 comprises adistal body 2414. The proximal end of distal body is connected to two ormore clamping arms 2416. One or more gaps are located between two ormore clamping arms 2416. Clamping arms 2416 enclose a central cavity2417 that is substantially collinear with lumen 2412 of screw cap 2402.The proximal ends of clamping arms 2416 comprise a tapered region 2418.Tightening screw cap 2402 over distal handle 2406 causes a region ofscrew cap 2402 to slide over tapered region 2418. This in turn displacesthe proximal regions of clamping arms 2416 in a radially inwarddirection. Thus, clamping arms 2416 can clamp on a device located in thehollow region that is enclosed by clamping arms 2416. Similarly,loosening screw cap 2402 over distal handle 2406 causes clamping arms2416 to release a device located in the hollow region that is enclosedby clamping arms 2416. In one embodiment of a method of folding aballoon of a balloon catheter, an uninflated balloon is inserted in thehollow region that is enclosed by clamping arms 2416. Thereafter, theballoon is partially inflated such that portions of the balloon enterone or more gaps located between two or more clamping arms 2416.Thereafter, screw cap 2402 is tightened over distal handle 2406.Thereafter, the balloon is deflated. Simultaneously, folding tool 2400is rotated to create one or more folds in the balloon.

Folding tool 2300 and folding tool 2400 may comprise a centering elementto allign the shaft of a balloon catheter with the central axis of thefolding tools. In one embodiment, the centering element comprises acentering wire attached to the folding tool. The shaft of the ballooncatheter slides over the centering wire. This alligns the shaft of theballoon catheter with the central axis of the folding tool.

FIG. 25 shows a catheter 2500 that is useable for simultaneousirrigation and aspiration. This catheter 2500 comprises an inner tube2502 enclosing an inner lumen 2504. Inner tube 2502 may be made ofsuitable biocompatible materials including, but not limited to metalse.g. stainless steel, titanium, Nickel-titanium alloy (e.g., Nitinol),etc.; polymers e.g. Nylon, Pebax, PEEK, polyethylene, etc. The proximalend of inner tube 2502 comprises a suitable hub such as a female luerlock 2505. Inner tube 2502 is surrounded by an outer tube 2506. Outertube 2506 may be made of suitable biocompatible materials including, butnot limited to metals e.g. stainless steel, titanium, Nickel-titaniumalloy (e.g., Nitinol), etc.; polymers e.g. Nylon, Pebax, PEEK,polyethylene, etc. In one embodiment, inner tube 2502 has an innerdiameter of 0.040 inches and an outer diameter of 0.050 inches and outertube 2506 has an inner diameter of 0.080 inches and an outer diameter of0.092 inches. The distal end of outer tube 2506 is attached to innertube 2502 to create a fluid-tight distal seal 2508. The region betweenouter tube 2506 and inner tube 2502 encloses an outer lumen 2510. Thedistal region of outer tube 2506 comprises one or more openings orperforations 2512 that are in fluid communication with outer lumen 2510.The proximal end of outer tube 2506 is enclosed by a Y-connector 2514 asshown in FIG. 25. A side arm of Y-connector 2514 is in fluidcommunication with outer lumen 2510. The proximal end of the side armcomprises a hub 2516 such as a luer lock. Y-connector 2514 is attachedto female luer lock 2505 to create a fluid-tight proximal seal 2518. Inone embodiment, catheter 2500 further comprises a hypotube surroundingouter tube 2506. Catheter 2500 may be used to simultaneously introducefluids into and suction fluids out of a target anatomy such as aparanasal sinus, openings or passageways leading to a paranasal sinus,etc. In one method embodiment, outer lumen 2510 is used to introduce oneor more fluids into the target anatomy. Inner lumen 2504 is used tosuction out one or more fluids from the target anatomy. In anotherembodiment, inner lumen 2504 is used to introduce one or more fluidsinto the target anatomy. Outer lumen 2510 is used to suction out one ormore fluids from the target anatomy. In this embodiment, one or moreopenings or perforations 2512 may be made larger to prevent blockage bymaterials being suctioned into outer lumen 2510.

Image guided surgery (IGS) procedures (sometimes referred to as“computer assisted surgery”) were first developed for use inneurosurgery and have now been adapted for use in certain ENT surgeries,including sinus surgeries. See, Kingdom T. T., Orlandi R. R.,Image-Guided Surgery of the Sinuses: Current Technology andApplications, Otolaryngol. Clin. North Am. 37(2):381-400 (April 2004).Generally speaking, in a typical IGS procedure, a digital tomographicscan (e.g., a CT or MRI scan) of the operative field (e.g., the nasalcavities and paranasal sinuses) is obtained prior to surgery. Aspecially programmed computer is then used to convert the digitaltomographic scan data into a digital map. During surgery, sensorsmounted on the surgical instruments send data to the computer indicatingthe position of each surgical instrument. The computer correlates thedata received from the instrument-mounted sensors with the digital mapthat was created from the preoperative tomographic scan. One or moreimage(s) is/are then displayed on a monitor showing the tomographic scanalong with an indicator (e.g., cross hairs or an illuminated dot) of thereal time position of each surgical instrument. In this manner, thesurgeon is able to view the precise position of each sensor-equippedinstrument relative to the surrounding anatomical structures shown onthe tomographic scan. Various embodiments of adapter devices comprisingimage guidance sensors are disclosed herein. Such adapter devices areadapted to be fitted to one or more devices that are being introduced inthe anatomy. This enables a user to view the real time position of theone or more devices that are being introduced in the anatomy. Forexample, FIGS. 26-26B show a navigation adapter adapter that may beattached to the proximal end of a catheter, seeker, cannula, or anyother device to facilitate mounting of navigation unit (e.g., anavigation module, localizer or other apparatus such as sensor(s),emitter(s), transmitter(s), reflector(s), etc. that are useable inconjunction with a navigation system. The particular navigationapparatus may be selected from the various navigation apparatusdisclosed herein or in one of the patent applications incorporatedherein by reference. In the example of FIG. 26, the navigation adapter2600 comprises an elongate body 2602 comprising a lumen. Elongate body2602 may be made of suitable biocompatible materials including, but notlimited to metals e.g. stainless steel, titanium, etc.; polymers e.g.Nylon, Pebax, PEEK, polyethylene, etc. The outer surface of elongatebody 2602 may be roughened. The distal end of elongate body 2602comprises a first hub 2604. In one embodiment, first hub 2604 is a maleluer lock. The proximal end of elongate body 2602 comprises a second hub2606. In one embodiment, second hub 2606 is a female luer lock.Navigation adapter 2600 further comprises a tracking system for imageguided surgery. Navigation adapter 2600 is adapted to be fixed to adevice being introduced in the anatomy. The position of the device canthen be tracked using the tracking system located on navigation adapter2600. Thus, suitable rigid catheters or guide devices may be trackedusing existing tracking systems. Similarly, suitable devices withmalleable regions may also be tracked using existing tracking systems.The outer surface of elongate body 2602 may be roughened to increase thegrip of a user on navigation adapter 2600. In one embodiment, outersurface of elongate body 2602 is roughened by knurling.

FIG. 26A shows a perspective view of an embodiment of a navigationadapter comprising an optical navigation unit. Navigation adapter 2610comprises an elongate body 2612 comprising a lumen. Elongate body 2612may be made of suitable biocompatible materials including, but notlimited to metals e.g. stainless steel, titanium, nickel-titanium alloyssuch as Nitinol, etc.; polymers e.g. Pebax, PEEK polyimide, etc.;composites, etc. The distal end of elongate body 2612 comprises a firsthub 2614. In one embodiment, first hub 2614 is a male luer lock. Theproximal end of elongate body 2612 comprises a second hub 2616. In oneembodiment, second hub 2616 is a female luer lock. Navigation adapter2610 further comprises a navigation unit 2618 for image guided surgery.In one embodiment, navigation unit 2618 is an optical navigation unit.One example of such an optical navigation unit is a BrainLAB surgicalinstrument adapter. Navigation unit 2618 comprises an attachment region2620. One end of attachment region 2620 is connected to a series of arms2622 that extend radially outward from the axis of attachment region2620. The outer ends of arms 2622 comprise one or more optical energyemitters 2624 that emit optical energy. In one embodiment, opticalenergy emitters 2624 comprise infrared light emitting LEDs. In anotherembodiment, optical energy emitters 2624 comprise a reflecting surfacethat reflects externally generated optical energy reaching the surfaceof optical energy emitters 2624. A camera is positioned such that itreceives the optical energy emitted from optical energy emitters 2624.The camera is then used to track the position and orientation ofnavigation adapter 2610. Other examples of navigation unit 2618 include,but are not limited to navigation units comprising reflective passiveelements, light emitting diodes, transmitters or receivers of energy(e.g. optical energy, radiofrequency energy, etc.), a combination of towor more of the abovementioned navigation technologies, etc. Navigationadapter 2610 is adapted to be fixed to a diagnostic, therapeutic oraccess device 2626 being introduced in the anatomy. Device 2626 maycomprise a curved, angled or bent distal end 2628. The position of thedevice can then be tracked using the navigation unit 2618 located onnavigation adapter 2610. Thus, suitable rigid catheters or guide devicesmay be tracked using existing image guidance systems. One example of anoptical image guidance system that is useable in ENT and sinus surgeryis the LandmarX Evolution® ENT II Image Guidance System available fromMedtronic Xomed Surgical Products, Inc., Jacksonville, Fla. The outersurface of elongate body 2612 may be roughened to increase the grip of auser on navigation adapter 2610. In one embodiment, outer surface ofelongate body 2612 is roughened by knurling. In one method embodiment, asurgical navigation modality is attached to a rigid device disclosedherein, and the position and orientation of the distal tip of the rigiddevice is calibrated to the position and orientation of the imagingmodality. Thereafter, the rigid device is used to perform a diagnostic,therapeutic or access procedure. If the position or orientation of therigid device changes with respect to the position or orientation of thesurgical navigation modality, the position and orientation of the distaltip of the rigid device may be re-calibrated to the position andorientation of the imaging modality. Such a re-calibration may benecessary for example when a user bends or shapes the distal tip of arigid device comprising a malleable or shapeable distal tip.

FIG. 26B shows a perspective view of an embodiment of a navigationadapter comprising an electromagnetic navigation unit. In image guidancesystems that employ electromagnetic sensors/tracking systems,radiofrequency electromagnetic sensors (e.g., electromagnetic coils) areplaced on the surgical instruments and on a localizer frame worn by thepatient. A transmitter is positioned near the operative field. Thetransmitter transmits signals that are received by theinstrument-mounted sensors. The tracking system detects variations inthe electromagnetic field caused by the movement of theinstrument-mounted sensors relative to the transmitter. Examples ofcommercially available electromagnetic IGS systems that have been usedin ENT and sinus surgery include the ENTrak Plus™ and InstaTrak ENT™systems available from GE Medical Systems, Salt Lake City, Utah. Otherexamples of electromagnetic image guidance systems that may be modifiedfor use in accordance with the present invention include but are notlimited to those available from Surgical Navigation Technologies, Inc.,Louiville, Colo., Biosense-Webster, Inc., Diamond Bar, Calif. andCalypso Medical Technologies, Inc., Seattle, Wash. Navigation adapter2630 comprises an elongate body 2632 comprising a lumen. Elongate body2632 may be made of suitable biocompatible materials including, but notlimited to metals e.g. stainless steel, titanium, etc.; polymers e.g.Nylon, Pebax, PEEK, polyethylene, etc. The distal end of elongate body2632 comprises a first hub 2634. In one embodiment, first hub 2634 is amale luer lock. The proximal end of elongate body 2632 comprises asecond hub 2636. In one embodiment, second hub 2636 is a female luerlock. Navigation adapter 2630 further comprises a radiofrequencyelectromagnetic sensor 2638 for image guided surgery. Radiofrequencyelectromagnetic sensor 2638 is attached to elongate body 2632 by anattachment region 2640. In one embodiment, radiofrequencyelectromagnetic sensor 2638 is attached to an electrical cord 2642 totransmit data from radiofrequency electromagnetic sensor 2638 to anelectromagnetic image guidance system. Navigation adapter 2630 isadapted to be fixed to a diagnostic, therapeutic or access device 2644being introduced in the anatomy. Device 2644 may comprise a shapeable ormalleable distal tip 2646. The position of the device can then betracked using radiofrequency electromagnetic sensor 2638 located onnavigation adapter 2630. Thus, suitable rigid catheters or guide devicesmay be tracked using existing image guidance systems. The outer surfaceof elongate body 2632 may be roughened to increase the grip of a user onnavigation adapter 2630. In one embodiment, outer surface of elongatebody 2632 is roughened by knurling.

Similar navigation adapters can be designed wherein electromagneticsensor 2638 is replaced by other surgical navigation units. Examples ofsuch surgical navigation units include, but are not limited tonavigation units comprising reflective passive elements, light emittingdiodes, transmitters or receivers of energy (e.g. optical energy,radiofrequency energy, etc.), a combination of tow or more of theabovementioned navigation technologies, etc.

One or more of the devices disclosed herein may comprise a magneticnavigation element located at the distal region of the devices. Such amagnetic navigation element may comprise a permanent magnet or anelectromagnet. The distal region of the devices can then be navigatedthrough the anatomy by providing a magnetic field of specified directionand magnitude, positioned externally to the patient.

FIGS. 27A and 27B show top and side views respectively of a surgicalhand tool comprising a balloon catheter. FIG. 27A shows a surgical handtool 2700 comprising a hollow proximal body 2702 made of biocompatiblematerials including, but not limited to ABS, nylon, polyurethane,polyethylene, etc. Proximal body 2702 encloses a balloon catheter 2704.Balloon catheter 2704 comprises a balloon inflation port 2706 to inflatea balloon on balloon catheter 2704. Balloon inflation port 2706 emergesout of proximal body 2702 through a longitudinal slit 2708 throughproximal body 2702 such that balloon catheter 2704 can slide along theaxis of proximal body 2702. Balloon inflation port 2706 is connected toa suitable inflating device to inflate the balloon of balloon catheter2704. In this embodiment, balloon catheter 2704 is introduced into adesired region of the anatomy over a guidewire 2710. The proximal regionof guidewire 2710 may comprise a torquing device 2712. A user can usetorquing device 2712 to rotate, advance, retract, or torque guidewire2710. The distal region of proximal body 2702 comprises a suitable hubthat allows a guide catheter 2714 to attach to proximal body 2702. In analternate embodiment, guide catheter 2714 is permanently attached toproximal body 2702. In this embodiment, guide catheter 2714 comprises anelongate tubular element 2716 made of suitable biocompatible materialsincluding, but not limited to PEEK, Pebax, Nylon, Polyimide, ABS, PVC,polyethylene, etc. The proximal region of tubular element 2716 may becovered by a hypotube 2718 made of suitable biocompatible metals orpolymers. The proximal end of tubular element 2716 is attached to asuitable hub 2720. Hub 2720 allows the reversible attachment of guidecatheter 2714 to proximal body 2702. In one embodiment, hub 2720 is afemale luer lock that attached to a suitable hub on proximal body 2702.Thus, various guide catheters can be attached to the distal region ofproximal body 2702 to provide access to various anatomical regions. Thedistal end of tubular element 2716 may comprise an atraumatic tip 2722.The distal end of tubular element 2716 may comprise a curved, bent orangled region. FIG. 27B shows the side view of surgical hand tool 2700showing a handle 2724 attached to proximal body 2702.

FIGS. 27C through 27D show various steps of a method of dilating ananatomical region using the surgical hand tool shown in FIGS. 27A and27B. In FIG. 27C, surgical hand tool 2700 is introduced in the anatomy.Surgical hand tool 2700 is positioned such that the distal tip ofsurgical hand tool 2700 is located near an anatomical region to beaccessed. Thereafter, a guidewire 2710 is introduced through surgicalhand tool 2700 such that the distal tip of guidewire 2710 is locatednear an anatomical region to be accessed. During this step, guidewire2710 may be navigated through the anatomy using torquing device 2712. Inone embodiment, guidewire 2710 is positioned across a paranasal sinusostium to be dilated. Thereafter, in FIG. 27D, balloon catheter 2704 isadvanced over guidewire 2710 into the anatomy. This is done by pushingballoon inflation port 2706 in the distal direction. Thereafter, ballooncatheter 2704 is used to perform a diagnostic or therapeutic procedure.In one embodiment, balloon catheter 2704 is used to dilate an openingleading to a paranasal sinus such as a paranasal sinus ostium.

FIG. 27E shows a side view of a first alternate embodiment of a surgicalhand tool comprising a balloon catheter. The design of surgical handtool 2726 is similar to the design of surgical hand tool 2700. Surgicalhand tool 2726 comprises a hollow elongate body 2727 made ofbiocompatible materials including, but not limited to ABS, nylon,polyurethane, polyethylene, etc. Elongate body 2727 is attached to ahandle 2728 to allow a user to grasp surgical hand tool 2726. Elongatebody 2727 comprises a longitudinal slit 2729. Elongate body 2727encloses a balloon catheter 2730. Balloon catheter 2730 comprises aballoon inflation port 2731 to inflate a balloon on balloon catheter2730. Balloon inflation port 2731 emerges out of elongate body 2727through longitudinal slit 2729 such that balloon catheter 2730 can slidealong the axis of elongate body 2727. Balloon catheter 2730 is furtherconnected to a trigger 2732. Trigger 2732 is pivoted on elongate body2727 such that pulling trigger 2732 in the proximal direction causesballoon catheter 2730 to move in the distal direction. Similarly,pushing trigger 2732 in the distal direction causes balloon catheter2730 to move in the proximal direction Thus balloon catheter 2730 can bemoved by moving trigger 2732. The distal region of elongate body 2727comprises a suitable hub that allows a guide catheter 2733 to attach toelongate body 2727. In this embodiment, guide catheter 2733 comprises anelongate tubular element 2734 made of suitable biocompatible materialsincluding, but not limited to PEEK, Pebax, Nylon, polyethylene, etc. Theproximal region of tubular element 2734 may be covered by a hypotube2735 made of suitable biocompatible metals or polymers. The proximal endof tubular element 2734 is attached to a suitable hub 2736. Hub 2736allows the reversible attachment of guide catheter 2733 to elongate body2727. In one embodiment, hub 2736 is a female luer lock that attached toa suitable hub on elongate body 2727. Thus, various guide catheters canbe attached to the distal region of elongate body 2727 to provide accessto various anatomical regions. The distal end of tubular element 2734may comprise an atraumatic tip 2737. The distal end of tubular element2734 may comprise a curved, bent or angled region. In this embodiment,balloon catheter 2730 is introduced into a desired region of the anatomyover a guidewire 2738. The proximal region of guidewire 2738 maycomprise a torquing device 2739. A user can use torquing device 2739 torotate, advance, retract, or torque guidewire 2738. Surgical hand tool2726 can be used to introduce balloon catheter 2730 into a desiredanatomical region to perform a diagnostic or therapeutic procedure inthe anatomical region.

FIG. 27F shows a side view of a second alternate embodiment of asurgical hand tool comprising a balloon catheter. The design of surgicalhand tool 2740 is similar to the design of surgical hand tool 2726.Surgical hand tool 2740 further comprises a fluid delivery mechanism todeliver inflating fluid for inflating the balloon of balloon catheter2730. The fluid delivery mechanism comprises an elongate tube 2741connected to balloon inflation port 2731. Elongate tube 2741 is furtherconnected to a fluid reservoir 2742. In one embodiment, fluid reservoir2742 comprises a pressurized gas such as air, nitrogen, carbon dioxide,etc. The delivery of fluid from fluid reservoir 2742 to balloon catheter2730 is controlled by a valve 2743.

FIG. 27H shows partial sectional view of the surgical hand tool shown inFIG. 27F. The proximal region of elongate body 2727 compriseslongitudinal slit 2729. Elongate body 2727 encloses balloon catheter2730. The proximal end of balloon catheter 2730 comprises a Y shapedhub. The Y-shaped hub comprises balloon inflation port 2731. Ballooninflation port 2731 in turn is connected to elongate tube 2741.Guidewire 2738 enters elongate body 2727 through an opening in theproximal end of elongate body 2727.

FIG. 27G shows a perspective view of an embodiment of the valvearrangement of the device shown in FIG. 27F. The valve arrangementcomprises a three way valve 2743. In one embodiment, three way valve2743 is a three way luer valve. A first arm 2744 of three way valve 2743is connected by elongate tube 2741 to fluid reservoir 2742. A second arm2745 of three way valve 2743 is in fluid communication with the balloonof balloon catheter 2730. A third arm 2746 of three way valve 2743 isconnected to a drain or is open to the atmosphere. Third arm 2746 may beconnected to a syringe or a source of vacuum to deflate balloon ofballoon catheter 2730. Such an arrangement comprising a syringe or asource of vacuum connected to third arm 2746 is especially useful todeflate a non-compliant balloon. Three way valve 2743 further comprisesa control knob 2747. In a first position of control knob 2747, a fluidcommunication is created between first arm 2744 and second arm 2745. Ina second position of control knob 2747, a fluid communication is createdbetween second arm 2745 and third arm 2746. A user can turn control knob2747 in the first position to inflate the balloon of balloon catheter2730. The user can then turn control knob 2747 in the second position todeflate the balloon of balloon catheter 2730. Other suitable valvearrangements may also be used instead of a three way valve forcontrollably inflating or deflating the balloon of balloon catheter2730.

FIG. 28A shows a perspective view of an embodiment of a handheld ballooncatheter tool. Balloon catheter tool 2750 comprises a proximal region2751. Proximal region 2751 comprises a handle 2752 to enable a user tohold balloon catheter tool 2750. Balloon catheter tool 2750 furthercomprises a balloon catheter shaft 2753. In one embodiment, ballooncatheter shaft 2753 extends distally from the distal region of proximalregion 2751. In another embodiment, balloon catheter shaft 2753 extendstill the proximal end of proximal region 2751. Balloon catheter shaft2753 may further comprise a hypotube 2754 surrounding a region ofballoon catheter shaft 2753. The distal region of balloon catheter shaft2753 comprises an inflatable balloon 2755 that can be used to dilate oneor more regions of the anatomy. Balloon 2755 is inflated by a trigger2756 located adjacent to handle 2752. Trigger 2756 is connected to aplunger that is further connected to an inflating fluid reservoir.Pulling trigger 2756 causes the inflating fluid stored in an inflatingfluid reservoir to be delivered to balloon 2755 under pressure. Ballooncatheter tool 2750 may further comprise a flushing port 2757 to flush alumen of balloon catheter shaft 2753. During a procedure, a userinflates balloon 2755 to a desired pressure using the inflating fluidstored in the inflating fluid reservoir. The pressure in balloon 2755can be measured by a pressure sensor or gauge 2758 that is in fluidcommunication with the inflating fluid within balloon 2755. Ballooncatheter tool 2750 may further comprise a ratcheting mechanism 2759 toallow a user to pull trigger 2756 in incremental steps. This allows theuser to inflate balloon 2755 in incremental steps. Similarly, ballooncatheter tool 2750 may comprise a ratcheting mechanism to allow a userto release trigger 2756 in incremental steps after inflating balloon2755. This allows the user to deflate balloon 2755 in incremental steps.In one embodiment, balloon catheter tool 2750 can be advanced over aguidewire to a desired target location in the anatomy. In thisembodiment, balloon catheter tool 2750 may further comprise a proximalguidewire port 2760 that is in fluid communication with a guidewirelumen in balloon catheter shaft 2753. This enables balloon catheter tool2750 to be introduced over a guidewire into the anatomy. In anotherembodiment, balloon catheter tool 2750 comprises a fixed guidewire 2761at the distal tip of balloon catheter tool 2750 to navigate ballooncatheter tool 2750 through the anatomy. In one embodiment, ballooncatheter tool 2750 comprises a rotation knob 2662. Rotation knob 2762allows a user to rotate balloon catheter shaft 2753. Balloon cathetertool 2750 may further comprise one or more navigational modalitiesincluding, but not limited to radio opaque markers, electromagneticnavigational sensors, etc. The distal region of balloon catheter tool2750 may be introduced in the anatomy through a variety of introducingdevices disclosed herein including, but not limited to guide catheter620 of FIG. 6C.

FIG. 28B shows a perspective view of an embodiment of a detachablehandheld balloon catheter inflation tool. Detachable inflation tool 2770comprises a body 2771 comprising a handle 2772 to enable a user to holdinflation tool 2770. Detachable inflation tool 2770 attaches to aballoon catheter 2773. In one embodiment, a user is provided with a kitcomprising a detachable inflation tool 2770 and multiple ballooncatheters. In the embodiment shown in FIG. 28B, balloon catheter 2773comprises an elongate balloon catheter shaft 2774. The distal region ofballoon catheter shaft 2774 comprises an inflatable balloon 2775 thatcan be used to dilate one or more regions of the anatomy. The proximalregion of balloon catheter shaft 2774 is connected to a suitable hub2776 comprising a side port for inflating balloon 2775. In oneembodiment, balloon catheter shaft 2774 comprises a hypotube 2777surrounding a region of balloon catheter shaft 2775. Balloon 2775 isinflated by a trigger 2778 located adjacent to handle 2772. Trigger 2778is connected to a plunger that is further connected to an inflatingfluid reservoir. Pulling trigger 2778 causes an inflating fluid storedin the inflating fluid reservoir to be delivered to balloon 2755 underpressure. The inflating fluid is delivered through a fluid delivery port2779 that attaches to the side port of hub 2776. During a procedure, auser inflates balloon 2775 to a desired pressure using the inflatingfluid stored in the inflating fluid reservoir. The pressure in balloon2775 can be measured by a pressure sensor or gauge 2780 that is in fluidcommunication with the inflating fluid within balloon 2775. Detachableinflation tool 2770 may further comprise a ratcheting mechanism 2781 toallow a user to pull trigger 2778 in incremental steps. This allows theuser to inflate balloon 2775 in incremental steps. Similarly, detachableinflation tool 2770 may comprise a ratcheting mechanism to allow a userto release trigger 2778 in incremental steps after inflating balloon2775. This allows the user to deflate balloon 2775 in incremental steps.In one embodiment, the combination of balloon catheter 2773 and ballooncatheter tool 2770 can be advanced over a guidewire to a desired targetlocation in the anatomy. In this embodiment, balloon catheter tool 2770may further comprise a proximal guidewire port 2782 that is in fluidcommunication with a guidewire lumen in balloon catheter shaft 2774.This enables balloon catheter tool 2770 to be introduced over aguidewire 2783 into the anatomy. In another embodiment, balloon catheter2773 comprises a fixed guidewire at the distal tip of balloon catheter2773 to navigate balloon catheter 2773 through the anatomy. In anotherembodiment, balloon catheter 2773 comprises a rapid exchange lumen. Therapid exchange lumen enables balloon catheter 2773 to be introduced overa suitable guidewire. Balloon catheter tool 2770 may further comprise aflushing port 2784 to flush a lumen of balloon catheter 2773. Ballooncatheter tool 2770 may further comprises one or more navigationalmodalities including, but not limited to radio opaque markers,electromagnetic navigational sensors, etc. The distal region of ballooncatheter 2773 may be introduced in the anatomy through a variety ofintroducing devices disclosed herein including, but not limited to guidecatheter 620 of FIG. 6C.

The balloon catheter tool of FIG. 28A or the detachable handheld ballooncatheter inflation tool of FIG. 28B may be designed to inflate a balloonto a fixed pressure. Alternatively, they may be designed to deliver afixed volume of inflating fluid to inflate a balloon.

Any of the handle assemblies of the tools described herein and in thepatent applications incorporated herein by reference may comprise arotatable handle. Such a rotatable handle may be designed to convert apart of a rotational force exerted by a user to a rectilinear force todraw components of the handle assembly towards each other. Oneembodiment of a rotatable handle is disclosed in U.S. Pat. No. 5,697,159(Lindén) titled ‘Pivoted hand tool’, the entire disclosure of which isexpressly incorporated herein by reference. Such designs of rotatablehandles may be used for handle assemblies including, but not limited toa) handle 2752 and trigger 2756 in FIG. 28A, b) handle 2772 and trigger2778 in FIG. 28B, etc.

FIG. 29 shows a perspective view of a hand-held squeezing device tobreak or deform one or more anatomical structures such a nasalturbinates. Squeezing device 2800 comprises a two or more of distalsqueezing elements that are used by a user to squeeze tissue locatedbetween the distal squeezing elements. Squeezing device 2800 can be usedto temporarily or permanently deform tissue, break tissue, etc. In theembodiment shown in FIG. 29, squeezing device 2800 comprises a proximalhandle element 2802 and a distal handle element 2804. Distal handleelement 2804 may comprise an opening 2806 to enable a user to insert oneor more fingers through opening 2806 to pull distal handle element 2804.Proximal handle element 2802 and distal handle element 2804 are hingedtogether by a first hinge 2808. A spring device 2810 is used to biasproximal handle element 2802 and distal handle element 2804 such thatthe proximal regions of proximal handle element 2802 and distal handleelement 2804 are spaced apart. In this embodiment, spring device 2810comprises a bent, elastic metal strip as shown. One end of the strip isfixed to proximal handle element 2802 and the other end of the stripslides over a surface of distal handle element 2804. The distal regionof proximal handle element 2802 is connected by a second hinge 2812 tothe proximal region of an elongate first distal element 2814. The distalregion of first distal element 2814 may comprise one or more compressionarms 2816 to compress tissue. Compression arms 2816 may be substantiallystraight or may comprise one or more bent, curved or angled regions. Inthis embodiment, the distal region of first distal element 2814comprises a single compression arm 2816. The distal region of distalhandle element 2804 is connected by a third hinge 2818 to the proximalregion of an elongate second distal element 2820. The distal region ofsecond distal element 2820 may comprise one or more compression arms2822 to compress tissue. Compression arms 2822 may be substantiallystraight or may comprise one or more bent, curved or angled regions. Inthis embodiment, the distal region of second distal element 2820comprises a two compression arm 2822. The curved middle regions of firstdistal element 2814 and second distal element 2820 are connected to eachother by a fourth hinge 2824. In one embodiment of a method of usingsqueezing device 2800, a user squeezes proximal handle element 2802 anddistal handle element 2804 towards each other. This causes the distalends of proximal handle element 2802 and distal handle element 2804 moveaway from each other. This in turn causes the proximal ends of firstdistal element 2814 and second distal element 2820 to move apart fromeach other. This in turn causes compression arm 2816 and compressionarms 2822 to move closer to each other. This squeezes tissue locatedbetween compression arm 2816 and compression arms 2822. In one methodembodiment, squeezing device 2800 is used to crush or break a region ofa nasal turbinate to gain access to a paranasal sinus ostium. Thevarious components of squeezing device 2800 may be made using suitablebiocompatible materials including, but not limited to stainless steel,titanium, etc. FIGS. 29A and 29B show enlarged views of the distalregion of the squeezing device of FIG. 29. FIG. 29A shows theorientation of compression arm 2816 and compression arms 2822 whensqueezing device 2800 is in an undeployed configuration. FIG. 29B showsthe orientation of compression arm 2816 and compression arms 2822 whensqueezing device 2800 is being used to squeeze tissue.

FIGS. 29C and 29D show a coronal section through a region of a humanhead showing the steps of temporarily or permanently breaking ordeforming a nasal turbinate NT using the squeezing device of FIG. 29. InFIG. 29C, squeezing device 2800 is introduced in the nasal cavity.Thereafter, squeezing devices 2800 is positioned such that compressionarm 2816 is located on one side of the nasal turbinate NT andcompression arms 2822 are located on the other side of the nasalturbinate. In FIG. 29D, a user deploys squeezing device 2800. Thiscauses compression arm 2816 and compression arms 2822 to squeeze theregion of the nasal turbinate NT located between compression arm 2816and compression arms 2822.

FIG. 29E shows a perspective view of a hand-held device to twist one ormore anatomical structures such a nasal turbinates. Twisting device 2830comprises two or more distal arms that are placed around an anatomicalstructure. Thereafter, the two or more arms are twisted to temporarilyor permanently deform or break the anatomical structure. In theembodiment shown in FIG. 29E, twisting device 2830 comprises a proximalhandle 2832, a middle region 2834 and two distal arms 2836. Proximalhandle 2832 may have a substantially larger outer diameter than themaximum width of the distal region of twisting device 2830 to enable auser to easily twist the anatomical structure. The various components ofsqueezing device 2800 may be made using suitable biocompatible materialsincluding, but not limited to stainless steel, titanium, etc. In onemethod embodiment, twisting device 2830 is used to deform or break aregion of a nasal turbinate to gain access to a paranasal sinus ostium.

FIGS. 29G and 29G show a coronal section through a region of a humanhead showing the steps of temporarily or permanently breaking ordeforming a nasal turbinate NT using the squeezing device of FIG. 29. InFIG. 29G, twisting device 2830 is introduced in the nasal cavity.Thereafter, twisting device 2830 is positioned such that one of arms2836 is located on one side of the nasal turbinate NT and the other ofarms 2836 is located on the other side of the nasal turbinate. In FIG.29G, a user twists twisting device 2830. This causes arms 2836 to twistthe region of the nasal turbinate NT located between arms 2836 totemporarily or permanently break or deform the nasal turbinate NT.

The devices disclosed in FIGS. 298 through 29G are especially useful totreat patients with narrow noses to controllably fracture a nasalturbinate to allow access to a paranasal sinus ostium.

The rigid or flexible endoscopes disclosed herein may have a range ofview ranging from 0 degrees to 145 degrees. The embodiments ofendoscopes comprising a curved, bent or angled region may bemanufactured by curving or bending the optical fibers before fusing theoptical fibers. The optical fibers may be fused for example by heatingthem to a temperature ranging from 500 to 700 degrees Celsius or byusing suitable epoxy adhesives to attach the optical fibers to eachother. The endoscopes may be made using reduced cladding thicknessoptical fibers to allow curved, bent or angled regions with a largeangle or curvature but a small radius of curvature. The endoscopes mayalso be made using glass/glass/polymer (GGP) multimode fiber such as theones made by 3M to allow curved, bent or angled regions with a largeangle or curvature but a small radius of curvature. For example, inembodiments of endoscopes that have a bent, curved or angled regionenclosing an angle of 90 degrees or more, the radius of curvature of thebent, curved or angled region may preferably be less than or equal to1.5 cm. Such endoscopes comprising curved, bent or angled regions with alarge angle or curvature but a small radius of curvature are especiallyuseful to enable a user to access the maxillary sinuses.

The embodiments herein have been described primarily in conjunction withminimally invasive procedures, but they can also be used advantageouslywith existing open surgery or laparoscopic surgery techniques. Forexample, the methods and devices disclosed herein may be combined withone or more techniques of Functional Endoscopic Sinus Surgery (FESS). InFESS, a surgeon may remove diseased or hypertrophic tissue or bone andmay enlarge the ostia of paranasal sinuses to restore normal drainage ofthe sinuses. It is typically performed with the patient under generalanesthesia using endoscopic visualization.

Although FESS continues to be the gold standard therapy for severesinuses, it has several shortfalls such as post-operative pain andbleeding associated with the procedure, failure to relieve symptoms in asignificant subset of patients, risk of orbital, intracranial andsinonasal injuries, etc. Replacing one or more steps of FESS may reducethe shortfalls associated with the traditional FESS. The following aresome examples of procedures involving a combination of FESS and theprocedures disclosed in this patent application and the patentapplications incorporated herein by reference.

1. In one combination procedure, a maxillary sinus is treated by balloondilation with or without total or partial removal of the uncinate. Totalor partial removal of the uncinate may make it easier or faster for somephysicians to visualize and access the maxillary sinus.

2. In another combination procedure, a maxillary sinus is treated byballoon dilation in conjunction with removal of a nasal turbinate.During this combination procedure, a part or the entire nasal turbinatee.g. the middle turbinate may be removed. Removing a part or the entiremiddle turbinate provides additional working space in the region medialto the uncinate for instruments. This may potentially make thecombination procedure easier or faster.

3. In another combination procedure, a sphenoid sinus ostium is treatedby balloon dilation in conjunction with ethmoidectomy. The step ofethmoidectomy may enable a physician to introduce a guide catheterthrough the middle meatus to the sphenoid sinus ostium. This maypotentially enable easy access to the sphenoid sinus ostium.

4. In another combination procedure, a frontal sinus is treated byballoon dilation in conjunction with middle turbinate resection and/orethmoidectomy. This combination procedure may make easier for aphysician to find, visualize or access the frontal sinus once anatomicalstructures like Ethmoid bulla, turbinate, etc. are removed or reduced.

5. In another type of combination procedures, multiple sinuses aretreated by balloon dilation with no or minimal tissue or bone removal.This is then followed by standard techniques to treat sinus disease.Examples of such combination procedures include:

5A. Frontal, maxillary, or sphenoid sinuses are treated by balloondilation. Also, ethmoidectomy is performed while preserving theuncinate. The presence of the uncinate may preserve the natural functionof the uncinate. This in turn may lead to lower incidence ofcomplications like infection, etc. in the sinuses.

5B. Any paranasal sinus may be treated by balloon dilation combined witha second procedure including, but not limited to ethmoidectomy,septoplasty, reduction of a turbinate (e.g. inferior turbinate, middleturbinate, etc.), etc.

6. Any of the procedures disclosed herein may be performed inconjunction with irrigation and suction of one or more paranasal sinuseswith a flexible catheter or rigid instrument. A flexible catheter isparticularly useful to reach regions that are difficult to access byrigid instruments. Such regions may be located in lateral aspects of thefrontal sinuses, the inferior or medial aspects of the maxillarysinuses, etc.

7. Any of the procedures disclosed herein may further include removal ofone or more polyps. Polyp removal by standard techniques such as usingshavers can be combined with balloon dilation of various paranasal sinusostia. Once one or more polyps are removed, one or more ostia ofparanasal sinuses may be dilated by balloon dilation.

8. In another type of combination procedures, balloon dilation of one ormore paranasal sinus ostia may be performed to revise a previouslyperformed surgery or in conjunction with standard endoscopic sinussurgery techniques. Examples of such procedures include:

8A. Treating scar formation over frontal recess: In this combinationprocedure, an attempt is made to access frontal recess with a guidewire.A balloon catheter is then passed over the guidewire. If the guidewireis unable to access the frontal sinus ostia because of scarring orbecause the frontal sinus ostia are too small, a surgical instrumente.g. curette or seeker may be used to open or puncture scar tissue oradhesions or the frontal sinus ostia. Such scar tissue or adhesions maybe caused for example due to infection, prior surgery, etc. Thereafter,the frontal sinus ostia may be dilated by balloon dilation.

8B. Combination procedures similar to the abovementioned combinationprocedure may be performed to treat scarring near sphenoid sinuses andmaxillary sinuses.

9. In another type of combination procedures, one or more paranasalsinuses e.g. a maxillary sinus may be accessed by an artificiallycreated opening leading to the sinuses. Thereafter, a diagnostic ortherapeutic procedure disclosed herein or in the patent documentsincorporated herein by reference may be performed. The artificiallycreated opening may be used to endoscopically visualize the placement ofdevices such as balloon catheters, guidewires, or other devices througha natural ostium of the paranasal sinus. The artificially createdopening may also be used to introduce one or more diagnostic,therapeutic or access devices. The artificially created opening may beused to introduce liquids including, but not limited to solutions ofantibiotics, solutions of anti-inflammatory agents, etc. Theartificially created opening may be made by using suitable devicesincluding, but not limited to drilling devices, chopping devices,puncturing devices, etc.

Some specific examples of hybrid procedures of the present invention areshown in the flow diagrams of FIGS. 30-33.

FIG. 30 shows steps in a method wherein an anatomical or pathologicalstructure, such as the uncinate process, a turbinate, the wall of anethmoid air cell, a polyp, etc. is removed or substantially modified anda dilator (e.g., the balloon of a balloon catheter) is positioned withinan opening of a paranasal sinus and used to dilate that opening. Removalor modification of the anatomical or pathological structure may provideclearer access to and/or visibility of certain anatomical structuresduring the procedure or during post-operative examinations andfollow-up.

FIG. 31 shows steps in a method where a dilator such as the balloon of aballoon catheter is positioned in the opening of a paransal sinus andused to dilate that opening and, either before or after such dilation,the cavity of the paranasal sinus is suctioned or irrigated. In caseswhere a balloon catheter or other dilator device having a through lumenis used to accomplish the dilation step, the irrigation and/or suctionstep may be carried out by passing fluid or negative pressure throughthe through lumen of the dilation catheter. Or, a guidewire may beadvanced into or near the sinus cavity during the dilation step and,thereafter, a suction and/or irrigation device may be advanced over suchguidewire and used to carry out the suction and/or irrigation step.

FIG. 32 shows steps in a method where scar or adhesion tissue has formedin a location that obstructs a lumen, orifice, or passageway (e.g., scartissue obstruction the opening of a paranasal sinus) and a puncturetract is initially formed in the scar or adhesion tissue. This may beaccomplished by pushing a needle, seeker, probe, guidewire or otherpenetrator through the tissue. Thereafter, a dilator (e.g., a ballooncatheter) is advanced into the puncture tract and is used to dilate thepuncture tract, thereby relieving the obstruction caused by the aberrantscar or adhesion tissue.

FIG. 33 shows steps in a method wherein a dilator (e.g., the balloon ofa balloon catheter) is placed in a pre-existing opening of a paranasalsinus, such as the natural ostium of the sinus (or a previouslysurgically altered ostium) and is used to dilate that opening. Also, aseparate opening is created in that paranasal sinus, either from thenasal cavity or through the exterior of the face (e.g., a bore hole,antrostomy or trephination). This may provide improved ventilationand/or drainage of the sinus cavity. Optionally, the two openings maythen be used to perform other procedures. For example, a “flow through”lavage may be carried out by passing lavage solution through one of theopenings and out of the other. Or, a device may be inserted through oneof the openings, leaving the other opening unobstructed. Or, thephysician may visualize (e.g., through an endoscope) through the newlycreated opening while treated the pre-existing opening or performingother diagnosis or treatment of the sinus cavity.

It is to be appreciated that the devices and methods of the presentinvention relate to the accessing and dilation or modification of sinusostia or other passageways within the ear nose and throat. These devicesand methods may be used alone or may be used in conjunction with othersurgical or non-surgical treatments, including but not limited to thedelivery or implantation of devices and drugs or other substances asdescribed in copending U.S. patent application Ser. No. 10/912,578entitled Implantable Devices and Methods for Delivering Drugs and OtherSubstances to Treat Sinusitis and Other Disorders filed on Aug. 4, 2004,issued as U.S. Pat. No. 7,361,168 on Apr. 22, 2008, the entiredisclosure of which is expressly incorporated herein by reference.

It is to be appreciated that the invention has been described hereabovewith reference to certain examples or embodiments of the invention butthat various additions, deletions, alterations and modifications may bemade to these examples and embodiments without departing from theintended spirit and scope of the invention. For example, any element orattribute of one embodiment or example may be incorporated into or usedwith another embodiment or example, unless to do so would render theembodiment or example unsuitable for its intended use. All reasonableadditions, deletions, modifications and alterations are to be consideredequivalents of the described examples and embodiments and are to beincluded within the scope of the following claims.

What is claimed is:
 1. A method of using an apparatus, the apparatuscomprising: (a) a handle assembly, wherein the handle assembly comprisesa body; (b) an actuator, wherein the actuator is movable relative to thebody; (c) a guide member extending distally from the handle assembly,wherein the guide member has a malleable distal region configured to beplastically deformable and a distal end; and (d) a dilation cathetercoaxially disposed with respect to the guide member, wherein thedilation catheter comprises a dilator that is sized and configured totransition between a non-expanded state and an expanded state; whereinthe dilation catheter is coupled with the actuator such that theactuator is operable to drive the dilation catheter relative to theguide member from a proximal position to a distal position; the methodcomprising: (a) inserting the guide member, including the malleabledistal region, into a head of a patient; (b) positioning the distal endadjacent to an anatomical passageway of an ear, nose or throat of thepatient; (c) moving the actuator relative to the body to advance thedilation catheter along the malleable distal region distally relative tothe guide member such that the dilator is positioned in the anatomicalpassageway; and (d) expanding the dilator to thereby dilate theanatomical passageway, (e) removing the dilator from the anatomicalpassageway, wherein the anatomical passageway remains dilated after thedilator is removed from the anatomical passageway.
 2. The method ofclaim 1, further comprising moving the actuator relative to the body toretract the dilation catheter proximally relative to the guide memberafter the anatomical passageway is dilated.
 3. The method of claim 2,wherein the act of moving the actuator relative to the body to advancethe dilation catheter distally further comprises advancing the dilationcatheter over a guidewire.
 4. The method of claim 1, further comprisingtranslating a guidewire relative to the guide member, wherein theguidewire is slidably disposed in the guide member.
 5. The method ofclaim 4, further comprising inserting the guidewire into the guidemember.
 6. The method of claim 4, wherein the act of translating theguidewire further comprises translating a guidewire actuator distallyrelative to the body to advance a distal portion of the guidewiredistally relative to the guide member such that a distal portion of theguidewire extends beyond the distal end of the guide member.
 7. Themethod of claim 4, further comprising rotating the guidewire to rotate adistal portion of the guidewire relative to the guide member.
 8. Themethod of claim 1, wherein the actuator is longitudinally positionedbetween a proximal end of the body and a distal end of the body.
 9. Themethod of claim 1, wherein the act of inserting the guide membercomprises inserting the guide member through a nostril of the patient.10. The method of claim 1, further comprising selecting the guide memberfrom a plurality of guide members based on the anatomical passageway tobe dilated.
 11. The method of claim 10, further comprising coupling theselected guide member to the body at a hub positioned at the distal endof the body and at a proximal end of the selected guide member, suchthat the guide member is removably attached to the handle assembly viathe hub.
 12. The method of claim 1, wherein the dilator is diverted froma first orientation that is parallel with a longitudinal axis of theguide member to a second orientation that is oblique to the longitudinalaxis when the dilation catheter is advanced distally.
 13. The method ofclaim 1, further comprising: (a) attaching a support device adjacent tothe nostril of the patient; and (b) assembling a portion of theapparatus to the support device to facilitate access to the anatomicalpassageway of the patient.
 14. A method of dilating an anatomicalpassageway of a patient with an apparatus, wherein the apparatuscomprises a handle assembly, a guide member, and a dilation catheterincluding a dilator, wherein the method comprises: (a) forming a bend inthe guide member; (b) inserting the guide member, including the formedbend, into an ear, nose, or throat of the patient to thereby position adistal end of the guide member near the anatomical passageway within theear, nose, or throat of the patient; (c) actuating an actuator of thehandle assembly to drive the dilation catheter distally relative to thehandle assembly and along the formed bend such that the dilator ispositioned in the anatomical passageway within the ear, nose, or throatof the patient; (d) actuating the dilation catheter to thereby expandthe dilator within the anatomical passageway within the ear, nose, orthroat of the patient to thereby dilate the anatomical passageway; and(e) removing the dilator from the anatomical passageway within the ear,nose, or throat of the patient, wherein the anatomical passageway withinthe ear, nose, or throat of the patient remains dilated after thedilator is removed from the anatomical passageway within the ear, nose,or throat of the patient.
 15. The method of claim 14, further comprisinginserting a guidewire through the anatomical passageway, wherein thedilation catheter is advanced along the guidewire to position thedilator in the anatomical passageway.
 16. The method of claim 15,wherein the act of inserting the guidewire through the anatomicalpassageway further comprises translating a guidewire actuator distallyrelative to the handle assembly.
 17. The method of claim 16, furthercomprising rotating the guidewire actuator relative to the handleassembly to rotate the guidewire relative to the distal end of the guidemember.
 18. The method of claim 14, wherein actuating the dilationcatheter comprises inflating the dilator.
 19. The method of claim 14,wherein actuating the actuator comprises moving the actuator relative toa grip member of the handle assembly.
 20. A method of using anapparatus, the apparatus comprising: (a) a handle assembly, wherein thehandle assembly comprises a body having a proximal end and a distal end,wherein the body includes a longitudinal channel having a closed firstend or a closed second end, wherein the body forms the closed first endor the closed second end; (b) an actuator longitudinally positionedbetween the proximal end and the distal end of the body, wherein theactuator is positioned within the longitudinal channel and protrudestransversely from the body; (c) a guide member extending distally fromthe handle assembly, wherein the guide member has a distal end; and (d)a dilation catheter coaxially disposed relative to the guide member,wherein the dilation catheter comprises a dilator that is expandable;the method comprising: (a) inserting the distal end of the guide memberinto a head of the patient; (b) positioning the distal end adjacent toan opening of the paranasal sinus of the patient; (c) moving theactuator distally along the longitudinal channel relative to the body todrive the dilation catheter distally relative to the guide member suchthat the dilator is positioned in a drainage passageway of the paranasalsinus; and (d) expanding the dilator to dilate the drainage passagewayof the paranasal sinus.